Optimizing Pain and Rehabilitation After Knee Arthroplasty (OPRA)

Optimizing Pain and Rehabilitation After Knee Arthroplasty - Randomized, Blinded Clinical Trial Comparing Continuous Femoral Nerve Block Versus Single Injection Femoral Nerve Block Versus Local Infiltration Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: continuous FNB; Other: single femoral nerve block; Other: local infiltration analgesia

Detailed Description

This will be a prospective, randomized, double blind study. Patients will be randomized using a computer-generated sequence to one of three groups:

Group 1: Continuous femoral nerve block group (cFNB) Group 2: Single injection femoral nerve block group (sFNB) Group 3: Local infiltration analgesia group (LIA)

Inclusion criteria: Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty.

Exclusion criteria: Allergy, intolerance, or contraindication to any study medication (see below), 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults undergoing primary, tri-compartmental knee arthroplasty

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: continuous FNB; 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; femoral nerve block (ropivacaine 0.5%, 20 mL) with femoral nerve block infusion 48 h (ropivacaine 0.2%, 5mL/h), placebo local infiltration
ACTIVE_COMPARATOR: single FNB; femoral nerve block (ropivacaine 0.5% 20 mL), placebo femoral nerve block infusion, placebo local infiltration	Other: single femoral nerve block; single femoral nerve block (ropivacaine 0.5%, 20 mL), placebo femoral nerve block infusion, placebo local infiltration
ACTIVE_COMPARATOR: LIA; placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia	Other: local infiltration analgesia; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Opioid consumption is a surrogate outcome for pain. A reduction in opioid consumption also confers benefits of reduced side effects - nausea, dizziness, sedation, respiratory depression	Cumulative 4 day consumption
Knee range of motion	Active and passive range of motion - physical outcome measure	Measured each postoperative day (4 day maximum) during daily physiotherapy session
Six minute walk test	Validated functional outcome measure after total knee arthoplasty	Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative
Timed up and go	Functional outcome measure	Measured once on postoperative day 2 during the physiotherapy session
WOMAC	Western Ontario and McMaster University Osteoarthritis Index - functional outcome measure questionnaire	Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)
LEFS	Lower extremity functional scale - functional outcome questionnaire	Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)
Incidence of motor block	weakness in quadriceps from femoral nerve block can delay physiotherapy and cause falls	Participants will be followed for the duration of hospital stay, an expected average of 4 days
Complications of femoral nerve block, local infiltration analgesia	hematoma, infection, persistent neurological deficit 6 weeks postoperatively	From date of randomization until the first postoperative visit at 6 weeks
Inability to ambulate/falls		Participants will be followed for the duration of hospital stay, an expected average of 4 days
Nausea		Participants will be followed for the duration of hospital stay, an expected average of 4 days
NRS for pain	Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain	The highest NRS will be assessed daily during the patient's physiotherapy session, as well as the highest NRS achieved at 2 weeks, 6 weeks, and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: The Physicians' Services Incorporated Foundation; Canadian Anesthesiologists' Society
• Investigators: Principal Investigator: Colin J McCartney, MBChB, Sunnybrook Health Sciences Centre; Study Director: Stephen Choi, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (ESTIMATE): June 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 011-2012