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Completed

NCT Number: NCT02411149

Adductor Canal Block and Recovery After Total Knee Replacement Surgery

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

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor Canal Block

Drug

Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.

Other names: ropivacaine with epinephrine

Adductor Canal Block with Morphine

Drug

Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)

Other names: ropivacaine with epinephrine and spinal intrathecal morphine

local infiltration

Drug

30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.

Other names: saline

Primary outcomes

  1. Timed Up and Go test

    Time frame: 2-3 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 outcomes

  1. Pain outcome - NRS

    Time frame: 2-3 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) .

  2. Analgesic outcomes - Cumulative systemic opioid consumption

    Time frame: 2-3 days post surgery

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

  3. Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia

    Time frame: 2-3 days post surgery

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

  4. Analgesic outcomes - Incidence of opioid-related side effects

    Time frame: 2-3 days post surgery

    Incidence of opioid-related side effects

  5. Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees

    Time frame: 2-3 days post surgery

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

  6. Secondary short-term physical and performance-based functional outcome measures - Distance walked

    Time frame: 2-3 days post surgery

    Distance walked

  7. Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay

    Time frame: 2-3 days post surgery

    Hospital length of stay

  8. Secondary short-term physical and performance-based functional outcome measures - Discharge destination

    Time frame: 2-3 days post surgery

    Discharge destination (home or rehabilitation facility)

  9. Medium-term self-reported functional outcome measures - WOMAC

    Time frame: baseline and 2-3 days post surgery

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

  10. Medium-term self-reported functional outcome measures - LEFS

    Time frame: baseline and 2-3 days post surgery

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial

Acronym: ACB in TKA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2015
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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