Optimizing Pain and Rehabilitation After Knee Arthroplasty (OPRA)

This study is currently recruiting participants.
Verified August 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborators:
Canadian Anesthesiologists' Society
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Colin McCartney, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01616836
First received: June 7, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Total Knee Arthroplasty
Other: continuous FNB
Other: single femoral nerve block
Other: local infiltration analgesia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Numeric Rating Scale for Pain [ Time Frame: 09h00 on postoperative day 2 ] [ Designated as safety issue: No ]
    Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: Cumulative 4 day consumption ] [ Designated as safety issue: No ]
    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

  • Knee range of motion [ Time Frame: Measured each postoperative day (4 day maximum) during daily physiotherapy session ] [ Designated as safety issue: No ]
    Active and passive range of motion - physical outcome measure

  • Six minute walk test [ Time Frame: Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative ] [ Designated as safety issue: No ]
    Validated functional outcome measure after total knee arthoplasty

  • Timed up and go [ Time Frame: Measured once on postoperative day 2 during the physiotherapy session ] [ Designated as safety issue: No ]
    Functional outcome measure

  • WOMAC [ Time Frame: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months) ] [ Designated as safety issue: No ]
    Western Ontario and McMaster University Osteoarthritis Index - functional outcome measure questionnaire

  • LEFS [ Time Frame: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months) ] [ Designated as safety issue: No ]
    Lower extremity functional scale - functional outcome questionnaire

  • Incidence of motor block [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: Yes ]
    weakness in quadriceps from femoral nerve block can delay physiotherapy and cause falls

  • Complications of femoral nerve block, local infiltration analgesia [ Time Frame: From date of randomization until the first postoperative visit at 6 weeks ] [ Designated as safety issue: Yes ]
    hematoma, infection, persistent neurological deficit 6 weeks postoperatively

  • Inability to ambulate/falls [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: Yes ]
  • Nausea [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]
  • NRS for pain [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616836

Contacts
Contact: Colin J McCartney, MBChB 416-480-4864 colin.mccartney@utoronto.ca
Contact: Stephen Choi, MD 416-480-4864 stephen.choi@sunnybrook.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Turlough O'Hare, MD    905-522-1155 ext 33853    turlough.ohare@gmail.com   
Principal Investigator: Turlough O'Hare, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Priya Somascanthan    416 967 8587    Priya.Somascanthan@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Anesthesiologists' Society
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Colin J McCartney, MBChB Sunnybrook Health Sciences Centre
Study Director: Stephen Choi, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Colin McCartney, Staff Anesthesiologist, Associate Professor Department of Anesthesia, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01616836     History of Changes
Other Study ID Numbers: 011-2012
Study First Received: June 7, 2012
Last Updated: August 13, 2013
Health Authority: Canada: Health Canada
Canada: Sunnybrook Health Sciences Centre - Research Ethics Board

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014