Magnesium Sulfate in Adductor Canal Blocks

NCT02581683 | Completed Phase 4

• 1 other identifier: ANAE-273-15
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

Proper analgesia after total knee arthroplasty (TKA) is important for encouraging early ambulation, which can facilitate improved patient outcomes and early hospital discharge. For pain control after TKA, adductor canal blocks (ACBs) improve upon the gold standard femoral nerve blocks (FNBs) since they do not cause as much quadriceps muscle weakening, while providing equivalent analgesia. Multimodal analgesia has become commonplace as a method of superior pain control with fewer side effects. Magnesium sulfate as an adjuvant to FNB local anesthetics can improve pain control after surgery; however, it also prolongs time to ambulation. There are no reports on the effect of magnesium sulfate in ACBs on analgesia after TKA. Thus the purpose of this randomized, double-blind, controlled trial is to determine whether magnesium sulfate given with local anesthetics via ACB can prolong analgesia, reduce pain scores and opioid consumption, and increase mobilization in TKA patients.

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic request

  Investigators will note the time lapsed between end of surgery and the first request for additional analgesia (given using patient controlled analgesia pumps, as is standard of care at the study institution).

  First occurrence during hospitalization (up to 72 hours postoperatively)

Secondary Outcomes (7)

• Cumulative morphine consumption

  Cumulative dose during the first 24 postoperative hours

• Number of steps taken

  Number of steps taken during postoperative days 1 and 2

• Pain

  2, 4, 8, 12, and 24 hours after adductor canal injection (or sham)

• Patient satisfaction

  Once, 24 hours after surgery

• Time to readiness for discharge

  Once, upon occurrence, within 72 hours after surgery

Study Arms (3)

Magnesium

EXPERIMENTAL

Participants in this arm will receive magnesium sulfate + ropivacaine via adductor canal block

Drug: Magnesium Sulfate; Drug: Ropivacaine

Non-magnesium

ACTIVE COMPARATOR

Participants in this arm will receive ropivacaine via adductor canal block

Drug: Ropivacaine

Sham

SHAM COMPARATOR

Participants in this arm will receive a sham adductor canal block

Other: Sham

Interventions

Magnesium Sulfate DRUG

Given via adductor canal block

Also known as: Sulfamag, Epsom salt, Health Canada DIN: 02139499

Magnesium

Ropivacaine DRUG

Given via adductor canal block

Also known as: Naropin

Magnesium; Non-magnesium

Sham OTHER

Sham adductor canal block

Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists classification score of 1 to 3
• Presenting for unilateral primary total knee arthroplasty
• age 18 to 85

You may not qualify if:

• inability to use a patient-controlled analgesia pump
• long-standing use of opioid medications (3 months or longer)
• history of chronic pain syndromes
• significant cardiovascular disease
• medical conditions that preclude the use of a regional anesthetic technique or any of the study drugs
• inability to read and understand English
• incompetent to give consent to study participation
• women who are pregnant or nursing

Sponsors & Collaborators

• Queen's University: lead

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

Location

Related Publications (20)

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  PMID: 11575536 BACKGROUND

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• Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14.

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• Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.

  PMID: 22012543 BACKGROUND

• Zoratto D, Phelan R, Hopman WM, Wood GCA, Shyam V, DuMerton D, Shelley J, McQuaide S, Kanee L, Ho AM, McMullen M, Armstrong M, Mizubuti GB. Adductor canal block with or without added magnesium sulfate following total knee arthroplasty: a multi-arm randomized controlled trial. Can J Anaesth. 2021 Jul;68(7):1028-1037. doi: 10.1007/s12630-021-01985-5. Epub 2021 May 26.

  PMID: 34041719 DERIVED

MeSH Terms

Interventions

Magnesium Sulfate; Ropivacaine; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vidur Shyam, MBBS, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, GFT

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

CA (2)