Clinical trial NCT01616836: Optimizing Pain and Rehabilitation After Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Arthroplasty
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Anesthesiologists' Society
name: The Physicians' Services Incorporated Foundation
First posted: 2012-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Numeric Rating Scale for Pain
timeFrame: 09h00 on postoperative day 2
Secondary outcomes:
measure: Opioid consumption
timeFrame: Cumulative 4 day consumption
measure: Knee range of motion
timeFrame: Measured each postoperative day (4 day maximum) during daily physiotherapy session
measure: Six minute walk test
timeFrame: Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative
measure: Timed up and go
timeFrame: Measured once on postoperative day 2 during the physiotherapy session
measure: WOMAC
timeFrame: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)
measure: LEFS
timeFrame: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)
measure: Incidence of motor block
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: Complications of femoral nerve block, local infiltration analgesia
timeFrame: From date of randomization until the first postoperative visit at 6 weeks
measure: Inability to ambulate/falls
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: Nausea
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: NRS for pain
timeFrame: 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
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Colin J McCartney, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Stephen Choi, MD
role: STUDY_DIRECTOR
References: