Optimizing Pain and Rehabilitation After Knee Arthroplasty

NCT01616836 | Completed Phase 3 DMC

• 1 other identifier: 011-2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. A single injection method also exists and may provide similar benefits. Both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. It is unknown if the pain control provided by LIA is as good as that of FNB. This study will compare the femoral nerve block, continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale for Pain

  Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria

  09h00 on postoperative day 2

Secondary Outcomes (11)

• Opioid consumption

  Cumulative 4 day consumption

• Knee range of motion

  Measured each postoperative day (4 day maximum) during daily physiotherapy session

• Six minute walk test

  Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative

• Timed up and go

  Measured once on postoperative day 2 during the physiotherapy session

• WOMAC

  Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)

Study Arms (3)

continuous FNB

ACTIVE COMPARATOR

Bolus femoral nerve block (ropivacaine 0.5% 20 mL), continuous infusion 48 hours (ropivacaine 0.2%, 5 mL/h), placebo local infiltration

Other: continuous FNB

single FNB

ACTIVE COMPARATOR

femoral nerve block (ropivacaine 0.5% 20 mL), placebo femoral nerve block infusion, placebo local infiltration

Other: single femoral nerve block

LIA

ACTIVE COMPARATOR

placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia

Other: local infiltration analgesia

Interventions

continuous FNB OTHER

femoral nerve block (ropivacaine 0.5%, 20 mL) with femoral nerve block infusion 48 h (ropivacaine 0.2%, 5mL/h), placebo local infiltration

continuous FNB

single femoral nerve block OTHER

single femoral nerve block (ropivacaine 0.5%, 20 mL), placebo femoral nerve block infusion, placebo local infiltration

single FNB

local infiltration analgesia OTHER

placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia (tricompartmental injection of 150 mL ropivacaine 0.2%, ketorolac 30 mg, epinephrine 10 microg/mL)

LIA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing primary, tri-compartmental knee arthroplasty

You may not qualify if:

• Allergy, intolerance, or contraindication to any study medication
• Inability to walk independently prior to TKA
• Inability to comprehend French or English
• Use of major tranquilizers
• ASA 4 or 5
• BMI \> 40
• Opioid tolerance (opioid consumption \> 30mg oral morphine or equivalent per day)
• Pregnancy

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Anesthesiologists' Society: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

• Colin J McCartney, MBChB

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Stephen Choi, MD

  Sunnybrook Health Sciences Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Associate Professor Department of Anesthesia

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 12, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

CA (2)