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Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty

Primary Purpose

Acute Pain, Regional Anesthesia Morbidity

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ropivacaine
bupivacaine
Sham Adductor Canal Catheter
Adductor Canal Catheter
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Adductor Canal Catheter, Arthroplasty, Replacement, Knee, Local infiltration of analgesia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40-85
  • American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. • Undergoing Unilateral, Primary, Total Knee Arthroplasty
  • English as native language

Exclusion Criteria:

  • Patient refusal
  • History of opioid dependence
  • Contraindication to peripheral nerve block • Pre-existing significant neuropathy

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adductor Canal Catheter

Local Infiltration of Analgesia

Arm Description

This group will receive ropivacaine 0.5% 15 ml for the adductor canal block under ultrasound guided nerve block. A multi-orifice catheter will be placed in the adductor canal and an infusion of ropivacaine 0.2% at 10 ml/hr will be continued for 72 hours.

Local infiltration using 20 ml of free bupivacaine solution (Marcaine 0.25% with epinephrine 1:200000, ) diluted with 40 ml of normal saline following implantation of the knee prosthesis, the solution will be injected into the vastus medialis (5 ml), medial retinaculum (5 ml), origin of MCL (5 ml) and LCL (5 ml), lateral portion of quadriceps tendon (5 ml), vastus lateralis (5 ml), and subcutaneous tissues especially along saphenous nerve distribution (30 ml). Postoperatively, a sham adductor canal catheter will be placed as in the ACC arm following stabilization in the PACU to infuse only normal saline with an initial bolus of 15 ml saline and infusion of saline at 10ml/hr for 72 hours.

Outcomes

Primary Outcome Measures

Post-operative pain via numeric rating scale at rest and with activity during each physical therapy session
postoperative pain as measured by numeric rating scale at rest and with movement during each physical therapy session.

Secondary Outcome Measures

Postoperative opioid consumption
Opioid consumption during hospitalization in oxycodone equivalents at 24, 48 and 72 hours
Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires
Assess post-surgical pain and function as measured by PainDetect and WOMAC questionnaires at 6-8 weeks post-operative compared to preoperative pain and function
Passive and Active Range of Motion during Physical Therapy
Assess quantitative passive and active range of motion during physical therapy as well as Timed up to Go (TUG) which is routine assessment during physical therapy.

Full Information

First Posted
October 22, 2015
Last Updated
December 13, 2021
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02603900
Brief Title
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
Official Title
A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Local Infiltration of Analgesia (LIA) Following Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).
Detailed Description
The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/ motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr > 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score, WOMAC score and baseline Pain Management Questionnaire. When designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the LIA group will receive sham adductor canal catheter. All ACC's for both study groups will be placed postoperatively in the PACU. Those collecting data will be blinded from identifying patients in the control group, as both groups will have ACC placed with same technique. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC. All adductor canal catheters will remain in for 72 hours. Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. Patients will be called daily for pain diary results. As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Regional Anesthesia Morbidity
Keywords
Adductor Canal Catheter, Arthroplasty, Replacement, Knee, Local infiltration of analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Catheter
Arm Type
Experimental
Arm Description
This group will receive ropivacaine 0.5% 15 ml for the adductor canal block under ultrasound guided nerve block. A multi-orifice catheter will be placed in the adductor canal and an infusion of ropivacaine 0.2% at 10 ml/hr will be continued for 72 hours.
Arm Title
Local Infiltration of Analgesia
Arm Type
Experimental
Arm Description
Local infiltration using 20 ml of free bupivacaine solution (Marcaine 0.25% with epinephrine 1:200000, ) diluted with 40 ml of normal saline following implantation of the knee prosthesis, the solution will be injected into the vastus medialis (5 ml), medial retinaculum (5 ml), origin of MCL (5 ml) and LCL (5 ml), lateral portion of quadriceps tendon (5 ml), vastus lateralis (5 ml), and subcutaneous tissues especially along saphenous nerve distribution (30 ml). Postoperatively, a sham adductor canal catheter will be placed as in the ACC arm following stabilization in the PACU to infuse only normal saline with an initial bolus of 15 ml saline and infusion of saline at 10ml/hr for 72 hours.
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
20 ml bupivacaine ( Marcaine 0.25% with epinephrine 1:200000, Hospira Inc. Lake Forest, IL) diluted with 40 ml of normal saline injected intraoperatively into the knee joint before closure.
Intervention Type
Device
Intervention Name(s)
Sham Adductor Canal Catheter
Intervention Description
Sham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal.
Intervention Type
Device
Intervention Name(s)
Adductor Canal Catheter
Intervention Description
Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.
Primary Outcome Measure Information:
Title
Post-operative pain via numeric rating scale at rest and with activity during each physical therapy session
Description
postoperative pain as measured by numeric rating scale at rest and with movement during each physical therapy session.
Time Frame
post-operative day #0 to post-operative day #3
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Opioid consumption during hospitalization in oxycodone equivalents at 24, 48 and 72 hours
Time Frame
post-operative day #0 to postoperative day # 3
Title
Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires
Description
Assess post-surgical pain and function as measured by PainDetect and WOMAC questionnaires at 6-8 weeks post-operative compared to preoperative pain and function
Time Frame
6-8 weeks after surgical date
Title
Passive and Active Range of Motion during Physical Therapy
Description
Assess quantitative passive and active range of motion during physical therapy as well as Timed up to Go (TUG) which is routine assessment during physical therapy.
Time Frame
POD #0 to postoperative day #2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40-85 American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. • Undergoing Unilateral, Primary, Total Knee Arthroplasty English as native language Exclusion Criteria: Patient refusal History of opioid dependence Contraindication to peripheral nerve block • Pre-existing significant neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime L Baratta, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18627367
Citation
Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
Results Reference
background
PubMed Identifier
21821506
Citation
Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
Results Reference
background
PubMed Identifier
21394001
Citation
Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
Results Reference
background
PubMed Identifier
22221014
Citation
Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
Results Reference
background
PubMed Identifier
20571832
Citation
Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
Results Reference
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Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty

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