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Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
block
adductor canal block
Adductor Canal Block plus IPACK Block
adductor Canal Block plus PAI Block
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Total knee arthroplasty, Peri articular infiltration, Ipack block, Adductor canal block

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

Exclusion Criteria:

  • Previous operation on same knee
  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI > 40
  • ASA IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)

Sites / Locations

  • Karaman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Adductor canal block

Adductor canal block plus IPACK

Adductor canal block plus PAI

Outcomes

Primary Outcome Measures

NRS scores
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

Secondary Outcome Measures

Opioid consumption
Analgesic consumption at 4-6-8-12-24 and 48 hours
Range of knee motion
Degrees of flexion
Complications
Complications
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Incidence of adverse events related to nerve block procedures
muscle weakness, systemic toxicity
Rate of postoperative nausea and vomiting
nausea, vomiting
Patient mobilization
Patient reporting time of first standing to the side of the bed and time up and go test 2 days

Full Information

First Posted
June 9, 2021
Last Updated
August 17, 2021
Sponsor
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04931966
Brief Title
Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty
Official Title
Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty: a Prospective Randomized Trial on Pain and Knee Function After Total Knee Artroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
August 8, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
105 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=35), where an adductor canal block, group B (N:35) where an adductor canal block with IPCAK, and group C (n=35) where an adductor canal block with PAI will be performed preoperatively. All patients will receive a standardized multimodal approach. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.
Detailed Description
Total knee replacement (TKP) is accepted as one of the major orthopedic surgery that most patients suffer from pain in the postoperative period. The primary aim of this research is to compare the analgesic efficacy of infiltration between the popliteal artery and capsule of the knee(IPACK) with the periarticular block when an additional adductor canal block is used. In the literature, adductor canal block(ACB) and sciatic nerve block are used as part of multimodal analgesia for postoperative pain management of patients undergoing TKP. Nevertheless, ACB is found less effective for pain originating from the posterior part of the knee. Sciatic nerve block and periarticular injection(PAI) are commonly used blocks to improve the analgesic effect of ACB. Besides this, ACB is effective for pain originated from the posterior part of the knee. IPACK block is performed under ultrasound guidance and targets the articular branches of tibial, common peroneal, and obturator nerves with sparing lower extremity motor function. Patients scheduled for knee surgery under spinal anesthesia are included fort his study. All groups will be applied 0.03 mg/kg midazolam iv, then spinal anesthesia will be applied to 15 mg 0.5 % heavy bupivacaine. Three groups of 105 patients will be included in the study. Adductor Canal Block (ACB) (Group A ) (n:35): After the patients are given the supine position, under the guidance of the ultrasound linear probe, 10-15cm proximal to the knee joint, under the sartorius muscle, next to the femoral artery. After the saphenous is observed, 0.25% 20 mL of bupivacaine will be given Adductor + İPACK Grup ( group B) (n: 35): Adductor canal 0.25% 20 mL of bupivacaine will be administered. After the knee is flexed, after the convex probe is placed in the popliteal space, 20 ml of 0.25% bupivacaine will be injected into the area between the popliteal artery and the femur called IPACK Adductor + PAI ( group C) (n: 35): Adductor canal 0.25% 20 mL of bupivacaine will be administered. Patients will receive 60 ml of local anesthetic cocktail intraoperatively by the surgeon. At the end of the operation to the peri-articular area (posterior capsule, collateral ligament, quadriceps muscle). Cocktail consists of 40 ml 0.25% bupivacaine + 8 ml 8 mg morphine+12 ml saline. Routine multimodal analgesia will be used for postoperative analgesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Total knee arthroplasty, Peri articular infiltration, Ipack block, Adductor canal block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Adductor canal block
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Adductor canal block plus IPACK
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Adductor canal block plus PAI
Intervention Type
Procedure
Intervention Name(s)
block
Intervention Description
Adductor canal block
Intervention Type
Procedure
Intervention Name(s)
adductor canal block
Intervention Description
adductor canal block bupivacain
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block plus IPACK Block
Intervention Description
Adductor Canal Block plus IPACK Block using bupivacaine
Intervention Type
Procedure
Intervention Name(s)
adductor Canal Block plus PAI Block
Intervention Description
Adductor Canal Block plus PAI Block using bupivacaine
Primary Outcome Measure Information:
Title
NRS scores
Description
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Analgesic consumption at 4-6-8-12-24 and 48 hours
Time Frame
4-6-8-12-24 and 48 hours
Title
Range of knee motion
Description
Degrees of flexion
Time Frame
48 hours
Title
Complications
Description
Complications
Time Frame
48 hours
Title
Patient satisfaction
Description
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Time Frame
48 hours
Title
Incidence of adverse events related to nerve block procedures
Description
muscle weakness, systemic toxicity
Time Frame
Post-op 24 to 72 hours
Title
Rate of postoperative nausea and vomiting
Description
nausea, vomiting
Time Frame
Post-op 24 to 48 hours
Title
Patient mobilization
Description
Patient reporting time of first standing to the side of the bed and time up and go test 2 days
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for total knee arthroplasty Exclusion Criteria: Previous operation on same knee Hepatic or renal insufficiency Younger than 18 years old and older than 85 Patients undergoing general anesthesia Allergy or intolerance to one of the study medications BMI > 40 ASA IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
Facility Information:
Facility Name
Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32694032
Citation
Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.
Results Reference
background
PubMed Identifier
30234517
Citation
Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
Results Reference
background

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Comparision of IPACK and Periarticular Block With Adductor Block Alone After Total Knee Artroplasty

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