Optimizing Pain and Rehabilitation After Knee Arthroplasty

NCT ID: NCT01616836

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

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

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

continuous FNB

Bolus femoral nerve block (ropivacaine 0.5% 20 mL), continuous infusion 48 hours (ropivacaine 0.2%, 5 mL/h), placebo local infiltration

Group Type: ACTIVE_COMPARATOR

continuous FNB

Intervention Type: 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 FNB

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

Group Type: ACTIVE_COMPARATOR

single femoral nerve block

Intervention Type: OTHER

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

LIA

placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia

Group Type: ACTIVE_COMPARATOR

local infiltration analgesia

Intervention Type: 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)

Interventions

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

Intervention Type: OTHER

single femoral nerve block

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

Intervention Type: 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Anesthesiologists' Society

OTHER

Sponsor Role: collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stephen Choi

Staff Anesthesiologist, Associate Professor Department of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin J McCartney, MBChB

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Stephen Choi, MD

Role: STUDY_DIRECTOR

Sunnybrook Health Sciences Centre

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

011-2012

Identifier Type: -

Identifier Source: org_study_id