MedPath

Adductor Canal Block and Recovery After Total Knee Replacement Surgery

Phase 4
Completed
Conditions
Total Knee Arthroplasty
Interventions
Drug: Adductor Canal Block
Drug: Local Infiltration
Drug: Adductor Canal Block with Morphine
Registration Number
NCT02411149
Lead Sponsor
University Health Network, Toronto
Brief Summary

This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment

Detailed Description

The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.

Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria
  • American Society of Anesthesiologists Physical Status I-III
  • 18 - 80 years of age
  • BMI 18 - 40
  • Scheduled for elective total knee replacement under spinal anesthesia
  • Able to ambulate independently with a standard wheeled walker as maximum mobility aid
Exclusion Criteria
  • Revision knee arthroplasty
  • Bilateral knee arthroplasty
  • Lack of mental ability to provide informed consent
  • Neuropathic pain or sensory disorders of the surgical limb
  • Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
  • Chronic opioid use defined as > 30 mg of daily oral morphine equivalents

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Adductor Canal BlockAdductor Canal BlockThis group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine
Local Inflitration OnlyLocal InfiltrationThis group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia: * 30 ml normal saline * 3ml 0.5% preservative-free bupivacaine
Adductor Canal Block with MorphineAdductor Canal Block with MorphineThis group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Primary Outcome Measures
NameTimeMethod
Timed Up and Go test2-3 days post srugery

TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.

Secondary Outcome Measures
NameTimeMethod
Pain outcome - NRS2-3 days post surgery

a) Pain scores assessed with an 11 point verbal numeric rating scale (NRS) where 0 is "no pain" and 10 is "the worst pain imaginable", both at rest and during active physiotherapy (measured daily for 3 days post-operatively) .

Analgesic outcomes - Cumulative systemic opioid consumption2-3 days post surgery

Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).

Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia2-3 days post surgery

Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.

Analgesic outcomes - Incidence of opioid-related side effects2-3 days post surgery

Incidence of opioid-related side effects

Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees2-3 days post surgery

Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)

Secondary short-term physical and performance-based functional outcome measures - Distance walked2-3 days post surgery

Distance walked

Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay2-3 days post surgery

Hospital length of stay

Secondary short-term physical and performance-based functional outcome measures - Discharge destination2-3 days post surgery

Discharge destination (home or rehabilitation facility)

Medium-term self-reported functional outcome measures - WOMACbaseline and 2-3 days post surgery

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively

Medium-term self-reported functional outcome measures - LEFSbaseline and 2-3 days post surgery

Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.

Trial Locations

Locations (1)

Toronto Western Hospital

🇨🇦

Toronto, Ontario, Canada

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