Adductor Canal Block and Recovery After Total Knee Replacement Surgery (ACB in TKA)

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

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

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: Local Infiltration; Drug: Adductor Canal Block; Drug: Adductor Canal Block with Morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: saline
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	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.; Other Names: ropivacaine with epinephrine
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)	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); Other Names: ropivacaine with epinephrine and spinal intrathecal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go test	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.	2-3 days post srugery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain outcome - NRS	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) .	2-3 days post surgery
Analgesic outcomes - Cumulative systemic opioid consumption	Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).	2-3 days post surgery
Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia	Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.	2-3 days post surgery
Analgesic outcomes - Incidence of opioid-related side effects	Incidence of opioid-related side effects	2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees	Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)	2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Distance walked	Distance walked	2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay	Hospital length of stay	2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Discharge destination	Discharge destination (home or rehabilitation facility)	2-3 days post surgery
Medium-term self-reported functional outcome measures - WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively	baseline and 2-3 days post surgery
Medium-term self-reported functional outcome measures - LEFS	Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.	baseline and 2-3 days post surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anahi Perlas, MD, University of Toronto. University Health Network. Toronto Western Hospital.

Publications and helpful links

General Publications

• 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. doi: 10.2106/JBJS.E.00344.
• 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. doi: 10.1097/00000542-199907000-00006.
• 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.
• Biswas A, Perlas A, Ghosh M, Chin K, Niazi A, Pandher B, Chan V. Relative Contributions of Adductor Canal Block and Intrathecal Morphine to Analgesia and Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):154-160. doi: 10.1097/AAP.0000000000000724.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Adductor Canal Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Morphine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 13-7016-A