Optimizing Pain and Rehabilitation After Knee Arthroplasty

Phase 3

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Other: continuous FNB; Other: single femoral nerve block; Other: local infiltration analgesia

• Registration Number: NCT01616836
• Lead Sponsor: Sunnybrook Health Sciences Centre

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

Study Timeline

• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous FNB	continuous FNB	Bolus femoral nerve block (ropivacaine 0.5% 20 mL), continuous infusion 48 hours (ropivacaine 0.2%, 5 mL/h), placebo local infiltration
single FNB	single femoral nerve block	femoral nerve block (ropivacaine 0.5% 20 mL), placebo femoral nerve block infusion, placebo local infiltration
LIA	local infiltration analgesia	placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale for Pain	09h00 on postoperative day 2	Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	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
Knee range of motion	Measured each postoperative day (4 day maximum) during daily physiotherapy session	Active and passive range of motion - physical outcome measure
Six minute walk test	Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative	Validated functional outcome measure after total knee arthoplasty
WOMAC	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
LEFS	Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)	Lower extremity functional scale - functional outcome questionnaire
Incidence of motor block	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
Complications of femoral nerve block, local infiltration analgesia	From date of randomization until the first postoperative visit at 6 weeks	hematoma, infection, persistent neurological deficit 6 weeks postoperatively
Inability to ambulate/falls	Participants will be followed for the duration of hospital stay, an expected average of 4 days
NRS for 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	Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain
Timed up and go	Measured once on postoperative day 2 during the physiotherapy session	Functional outcome measure
Nausea	Participants will be followed for the duration of hospital stay, an expected average of 4 days

Trial Locations

Locations (2)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada