Adductor Canal Block and Recovery After Total Knee Replacement Surgery

NCT02411149 | Completed Phase 4

• 1 other identifier: 13-7016-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Total Knee Arthroplasty

Keywords

Adductor Canal Block; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pain outcome - NRS

  2-3 days post surgery

• Analgesic outcomes - Cumulative systemic opioid consumption

  2-3 days post surgery

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

  2-3 days post surgery

• Analgesic outcomes - 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

  2-3 days post surgery

Study Arms (3)

Local Inflitration Only

PLACEBO COMPARATOR

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

Adductor Canal Block

ACTIVE COMPARATOR

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

Adductor Canal Block with Morphine

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: ropivacaine with epinephrine

Adductor Canal Block

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)

Also known as: ropivacaine with epinephrine and spinal intrathecal morphine

Adductor Canal Block with 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.

Also known as: saline

Local Inflitration Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Physical Status I-III
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

• 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.

  PMID: 20299989 BACKGROUND

• 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.

  PMID: 10422923 BACKGROUND

• 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.

  PMID: 16651569 BACKGROUND

• 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.

  PMID: 29315129 DERIVED

MeSH Terms

Interventions

Ropivacaine; Epinephrine; Morphine; Anesthesia, Local; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anahi Perlas, MD

  University of Toronto. University Health Network. Toronto Western Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 8, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

CA (1)