Adductor Canal Block and Recovery After Total Knee Replacement Surgery

Overview

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

Full Title of Study: “Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Drug: Adductor Canal Block
    • 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.
  • Drug: Adductor Canal Block with Morphine
    • 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)
  • Drug: Local Infiltration
    • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Local Inflitration Only
    • This 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
  • Active Comparator: Adductor Canal Block
    • This 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
  • Active Comparator: Adductor Canal Block with Morphine
    • This 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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) .
  • 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).
  • 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.
  • Analgesic outcomes – Incidence of opioid-related side effects
    • Time Frame: 2-3 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 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)
  • Secondary short-term physical and performance-based functional outcome measures – Distance walked
    • Time Frame: 2-3 days post surgery
    • Distance walked
  • 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
  • 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)
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anahi Perlas, MD, Principal Investigator, University of Toronto. University Health Network. Toronto Western Hospital.

References

Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15.

Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63.

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