Skip to main content
OpenTrials
Completed

NCT Number: NCT01616836

Optimizing Pain and Rehabilitation After Knee Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

single femoral nerve block

Other

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

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)

Primary outcomes

  1. Numeric Rating Scale for Pain

    Time frame: 09h00 on postoperative day 2

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

Secondary outcomes

  1. Opioid consumption

    Time frame: Cumulative 4 day 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

  2. Knee range of motion

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

    Active and passive range of motion - physical outcome measure

  3. Six minute walk test

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

    Validated functional outcome measure after total knee arthoplasty

  4. Timed up and go

    Time frame: Measured once on postoperative day 2 during the physiotherapy session

    Functional outcome measure

  5. WOMAC

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

    Western Ontario and McMaster University Osteoarthritis Index - functional outcome measure questionnaire

  6. LEFS

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

    Lower extremity functional scale - functional outcome questionnaire

  7. Incidence of motor block

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

    weakness in quadriceps from femoral nerve block can delay physiotherapy and cause falls

  8. Complications of femoral nerve block, local infiltration analgesia

    Time frame: From date of randomization until the first postoperative visit at 6 weeks

    hematoma, infection, persistent neurological deficit 6 weeks postoperatively

  9. Inability to ambulate/falls

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

  10. Nausea

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

  11. 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

    Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Anesthesiologists' Society
  • The Physicians' Services Incorporated Foundation

Registry information

Official study 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

Acronym: OPRA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2012
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.