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Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty

Primary Purpose

Arthroplasty, Replacement, Knee, Analgesia, Rehabilitation

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pain scores (numerical rating scale at rest and motion)
Secondary outcomes
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, adductor canal block, Local infiltration, Regional analgesia, Pain, Postoperative, Rehabilitation, Muscle power

Eligibility Criteria

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

Inclusion Criteria:

  • Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adductor canal block

Local infiltration

Arm Description

Allocation of which limb is to receive adductor canal block 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.

Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure.

Outcomes

Primary Outcome Measures

Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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,
Pain score
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

Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
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)
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)
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)
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)
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 questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Functional questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Functional questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
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 19, 2022
Last Updated
March 9, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05439343
Brief Title
Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty
Official Title
Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 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
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
Detailed Description
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Analgesia, Rehabilitation
Keywords
Arthroplasty, Replacement, Knee, adductor canal block, Local infiltration, Regional analgesia, Pain, Postoperative, Rehabilitation, Muscle power

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a prospective, single-centered, double-blinded, randomized controlled trial. We intend to compare two methods of postoperative analgesia, adductor canal block (ACB) and multimodal local infiltration (LI), simultaneously in patients receiving bilateral total knee arthroplasty. In other words, the patient will receive ACB in one knee and LI in the other knee after TKA surgery. Because this study is designed to apply these two methods respectively on either knee of the same patient, the relative analgesic efficacy can be assessed simultaneously. Like matched-pair designed study, this method can eliminate some confounding factors affecting pain scores.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcomes assessor will not know which kind of interventions (adductor canal block and local infiltration) is performed on which knee.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor canal block
Arm Type
Experimental
Arm Description
Allocation of which limb is to receive adductor canal block 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.
Arm Title
Local infiltration
Arm Type
Experimental
Arm Description
Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure.
Intervention Type
Other
Intervention Name(s)
Pain scores (numerical rating scale at rest and motion)
Intervention Description
As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Intervention Type
Other
Intervention Name(s)
Secondary outcomes
Intervention Description
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. 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 knee joints.
Primary Outcome Measure Information:
Title
Pain score
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 (the day before surgery)
Title
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
The day of discharge
Title
Pain score
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
Knee range of motion
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
Baseline (the day before surgery)
Title
Knee range of motion
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
Knee range of motion
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
Knee range of motion
Description
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Time Frame
the day of discharge
Title
Knee range of motion
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
Knee muscle power
Description
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Time Frame
Baseline (the day before surgery)
Title
Knee muscle power
Description
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Time Frame
Hour 24 after surgery
Title
Knee muscle power
Description
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Time Frame
Hour 72 after surgery
Title
Knee muscle power
Description
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Time Frame
the day of discharge
Title
Knee muscle power
Description
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Time Frame
Month 3 after surgery
Title
Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Time Frame
Baseline (the day before surgery)
Title
Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Time Frame
Hour 24 after surgery
Title
Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Time Frame
Hour 72 after surgery
Title
Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Time Frame
the day of discharge
Title
Six minute walk test
Description
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Time Frame
Month 3 after surgery
Title
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 (the day before surgery)
Title
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
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
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
the day of discharge
Title
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 questionnaires
Description
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Time Frame
Baseline (the day before surgery)
Title
Functional questionnaires
Description
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Time Frame
the day of discharge
Title
Functional questionnaires
Description
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
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 (the day before 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 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
the 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: Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis. Exclusion Criteria: American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.
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

12. IPD Sharing Statement

Plan to Share IPD
No

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Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty

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