Recruiting

Bupivacaine & Magnesium

Sponsor:

Wayne State University

Code:

NCT05091138

Conditions

Post-operative Pain, Acute

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Adding Magnesium as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty

Adding Buprenorphine as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty

Study Details

Brief summary:

The purpose of this study is to compare the use of magnesium and bupivacaine to buprenorphine and bupivacaine in post-operative adductor canal blocks (ACB); the study will determine if one combination can result in decreased opioid consumption and improved pain management for patients after same-day discharge total knee arthroplasty (TKA) .

The investigators will assess whether the addition of magnesium to bupivacaine will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when buprenorphine is added to bupivacaine.

Conditions

Post-operative Pain, Acute

Opioid Use

Study ID

NCT05091138

Start date

Oct 12, 2021

Status verified date

Oct, 2021

Completion date

Oct 1, 2022

Anticipated

Primary completion date

Oct 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing unilateral primary total knee arthroplasty with spinal anesthetic and MAC followed by a unilateral adductor canal block with ultrasound guidance.

Exclusion Criteria:

  • Patients on chronic anticoagulation upon admission
  • Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) or significant platelet dysfunction
  • Patients with prior back surgery or leg surgery that precludes spinal or regional anesthesia
  • Infection at sites for regional/spinal anesthesia
  • Allergy to local anesthetics

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Mg and Bupivacaine

Patients in this arm (selected randomly) will receive an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine and 150mg of Mg.

active comparator: Buprenorphine and Bupivacaine

Patients in this arm (selected randomly) will receive an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine and 300 mcg of buprenorphine.

Interventions

Adding Magnesium as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty

Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate in the block and the other half will receive 300 mcg of buprenorphine in the block.

Adding Buprenorphine as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty

Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate in the block and the other half will receive 300 mcg of buprenorphine in the block.

Primary outcome measure

  • Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery [ Time Frame: The first 24 hours after surgery ]
  • Total opioid consumption (oral morphine equivalents) in the second 24 hours after surgery [ Time Frame: The second 24 hours after surgery ]
  • Visual analog scale (VAS) pain score at 24 hours after surgery [ Time Frame: 24 hours after surgery ]
  • Visual analog scale (VAS) pain score at 48 hours after surgery [ Time Frame: 48 hours after surgery ]

Central Contacts and Locations

Central contacts

Sandeep Krishnan, M.D.

(248) 858-6068sakrishna@med.wayne.edu

Farhad Ghoddoussi, Ph.D.

(248) 858-6068fghoddoussi@med.wayne.edu

Locations

St. Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Lena Anderson

248-858-6068leanders@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Oct 25, 2021

Last verified

Oct, 2021

Keywords

  • Same-day discharge total knee arthroplasty; Magnesium; Adductor canal block; Post-operative opioid consumption; Post-operative pain management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2021-10-25.