Optimizing Pain and Rehabilitation After Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

— OPRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616836
• Other study ID #: 011-2012
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2012
• Last updated: April 12, 2016
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Sunnybrook Health Sciences Centre - Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Anesthesiologists' Society, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Knee range of motion	Active and passive range of motion - physical outcome measure	Measured each postoperative day (4 day maximum) during daily physiotherapy session	No
Secondary	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	No
Secondary	Timed up and go	Functional outcome measure	Measured once on postoperative day 2 during the physiotherapy session	No
Secondary	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)	No
Secondary	LEFS	Lower extremity functional scale - functional outcome questionnaire	Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Inability to ambulate/falls		Participants will be followed for the duration of hospital stay, an expected average of 4 days	Yes
Secondary	Nausea		Participants will be followed for the duration of hospital stay, an expected average of 4 days	No
Secondary	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	No