NCT02603900

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

October 22, 2015

Last Update Submit

December 13, 2021

Conditions

Acute PainRegional Anesthesia Morbidity

Keywords

Adductor Canal CatheterArthroplasty, Replacement, KneeLocal infiltration of analgesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    post-operative day #0 to post-operative day #3

Secondary Outcomes (3)

  • Postoperative opioid consumption

    post-operative day #0 to postoperative day # 3

  • Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires

    6-8 weeks after surgical date

  • Passive and Active Range of Motion during Physical Therapy

    POD #0 to postoperative day #2

Study Arms (2)

Adductor Canal Catheter

EXPERIMENTAL

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.

Drug: ropivacaineDevice: Adductor Canal Catheter

Local Infiltration of Analgesia

EXPERIMENTAL

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.

Drug: bupivacaineDevice: Sham Adductor Canal Catheter

Interventions

ropivacaineDRUG

15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.

Also known as: Naropin
Adductor Canal Catheter
bupivacaineDRUG

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.

Also known as: Marcaine
Local Infiltration of Analgesia
Sham Adductor Canal CatheterDEVICE

Sham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal.

Local Infiltration of Analgesia
Adductor Canal CatheterDEVICE

Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.

Adductor Canal Catheter

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

  • 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.

    PMID: 18627367BACKGROUND

  • 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.

    PMID: 21821506BACKGROUND

  • 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.

    PMID: 21394001BACKGROUND

  • 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.

    PMID: 22221014BACKGROUND

  • 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.

    PMID: 20571832BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

RopivacaineBupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jaime L Baratta, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2015

First Posted

November 13, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations

US(1)