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Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty

Primary Purpose

Arthroplasty, Replacement, Knee, Pain, Postoperative, Multimodal Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale
Rehabilitation physiotherapy
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring Arthroplasty, Replacement, Knee, Regional analgesia, multimodal analgesia, Rehabilitation, Recovery of Function

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Clinical diagnosis of knee osteoarthritis Must be aged between 20 to 90 years old Must be scheduled for unilateral total knee arthroplasty surgery Must agree to enroll into the clinical trial and have signed the written informed consent Exclusion Criteria: American Society of Anesthesiologists physical status class IV-V Elevated liver enzymes or liver failure Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL) Cardiac failure Organ transplantation recipient Stroke Major neurological deficit with lower extremity muscle weakness Sensory and motor disorders in lower limb Coagulopathy or thrombocytopenia Previous drug dependency Patients who used illicit drugs within six months Chronic use of opioids Allergy to local anesthetics and drug used in experiment Inability to walk independently Inability to comprehend pain assessment Refusal for implanting a continuous peripheral nerve catheter Refusal for enrolling in study

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single-injection ACB combined with IV-PCA morphine

Continuous adductor canal infusion combined with intravenous NSAID

Arm Description

Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.

Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.

Outcomes

Primary Outcome Measures

Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.

Secondary Outcome Measures

Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Rehabilitation physiotherapy: Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Rehabilitation physiotherapy: Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Rehabilitation physiotherapy: Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Rehabilitation physiotherapy: Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia

Full Information

First Posted
May 23, 2022
Last Updated
March 9, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05669898
Brief Title
Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty
Official Title
Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
Detailed Description
The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Pain, Postoperative, Multimodal Analgesia
Keywords
Arthroplasty, Replacement, Knee, Regional analgesia, multimodal analgesia, Rehabilitation, Recovery of Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two-arm parallel assignment involves two groups of participants receiving multimodal analgesia after unilateral total knee arthroplasty. One group receives a single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia, and the other group receives continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-injection ACB combined with IV-PCA morphine
Arm Type
Active Comparator
Arm Description
Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.
Arm Title
Continuous adductor canal infusion combined with intravenous NSAID
Arm Type
Active Comparator
Arm Description
Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.
Intervention Type
Behavioral
Intervention Name(s)
Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.
Intervention Description
Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Intervention Type
Other
Intervention Name(s)
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale
Intervention Description
For the functional assessment both before and after TKA surgery.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation physiotherapy
Intervention Description
Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of both knees.
Primary Outcome Measure Information:
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Baseline (day of admission)
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 2 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 8 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 24 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 36 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 48 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 60 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Hour 72 after surgery
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
1 day of discharge
Title
Change in Pain scores at rest and motion
Description
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Time Frame
Month 3 after surgery
Secondary Outcome Measure Information:
Title
Rehabilitation physiotherapy: Knee flexion angle
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
Baseline (day of admission)
Title
Rehabilitation physiotherapy: Knee flexion angle
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
Hour 24 after surgery
Title
Rehabilitation physiotherapy: Knee flexion angle
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
Hour 72 after surgery
Title
Rehabilitation physiotherapy: Knee flexion angle
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
1 Day of discharge
Title
Rehabilitation physiotherapy: Knee flexion angle
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
Month 3 after surgery
Title
Rehabilitation physiotherapy: knee muscle strength
Description
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Time Frame
Baseline (day of admission)
Title
Rehabilitation physiotherapy: knee muscle strength
Description
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Time Frame
Hour 24 after surgery
Title
Rehabilitation physiotherapy: knee muscle strength
Description
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Time Frame
Hour 72 after surgery
Title
Rehabilitation physiotherapy: knee muscle strength
Description
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Time Frame
1 day of discharge
Title
Rehabilitation physiotherapy: knee muscle strength
Description
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Time Frame
Month 3 after surgery
Title
Rehabilitation physiotherapy: Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time Frame
Baseline (day of admission)
Title
Rehabilitation physiotherapy: Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time Frame
Hour 24 after surgery
Title
Rehabilitation physiotherapy: Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time Frame
Hour 72 after surgery
Title
Rehabilitation physiotherapy: Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time Frame
1 date of discharge
Title
Rehabilitation physiotherapy: Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time Frame
Month 3 after surgery
Title
Rehabilitation physiotherapy: Single leg stance test
Description
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Time Frame
Baseline (day of admission)
Title
Rehabilitation physiotherapy: Single leg stance test
Description
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Time Frame
Hour 24 after surgery
Title
Rehabilitation physiotherapy: Single leg stance test
Description
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Time Frame
Hour 72 after surgery
Title
Rehabilitation physiotherapy: Single leg stance test
Description
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Time Frame
1 day of discharge
Title
Rehabilitation physiotherapy: Single leg stance test
Description
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Time Frame
Month 3 after surgery
Title
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Description
For functional pain assessment
Time Frame
Baseline (day of admission)
Title
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Description
For functional pain assessment
Time Frame
1 day of discharge
Title
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Description
For functional pain assessment
Time Frame
Month 3 after surgery
Title
Functional questionnaire: Brief pain inventory (BPI) short form
Description
For functional pain assessment
Time Frame
Baseline (day of admission)
Title
Functional questionnaire: Brief pain inventory (BPI) short form
Description
For functional pain assessment
Time Frame
1 day of discharge
Title
Functional questionnaire: Brief pain inventory (BPI) short form
Description
For functional pain assessment
Time Frame
Month 3 after surgery
Title
Functional questionnaire: Lower extremity functional scale
Description
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Time Frame
Baseline (day of admission)
Title
Functional questionnaire: Lower extremity functional scale
Description
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Time Frame
1 date of discharge
Title
Functional questionnaire: Lower extremity functional scale
Description
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Time Frame
Month 3 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Baseline (day of admission)
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 2 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 8 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 24 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 36 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 48 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 60 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Hour 72 after surgery
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
1 day of discharge
Title
Adverse events
Description
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Time Frame
Month 3 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of knee osteoarthritis Must be aged between 20 to 90 years old Must be scheduled for unilateral total knee arthroplasty surgery Must agree to enroll into the clinical trial and have signed the written informed consent Exclusion Criteria: American Society of Anesthesiologists physical status class IV-V Elevated liver enzymes or liver failure Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL) Cardiac failure Organ transplantation recipient Stroke Major neurological deficit with lower extremity muscle weakness Sensory and motor disorders in lower limb Coagulopathy or thrombocytopenia Previous drug dependency Patients who used illicit drugs within six months Chronic use of opioids Allergy to local anesthetics and drug used in experiment Inability to walk independently Inability to comprehend pain assessment Refusal for implanting a continuous peripheral nerve catheter Refusal for enrolling in study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Sung Sung, MD, PhD
Phone
886-2-28757549
Ext
320
Email
cssung@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Yao Chiu, MD
Phone
886-9-76308308
Email
fychiu@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsu Ma, MD, PhD
Organizational Affiliation
Institutional Review Board, Taipei Veterans General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Sung Sung, MD, PhD
Phone
886-2-28757549
Ext
320
Email
cssung@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Fang-Yao Chiu, MD
Phone
886-9-76308308
Email
fychiu@vghtpe.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty

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