Are Adductor Canal Blocks With Bupivacaine and Added Magnesium Better at Managing Post-operative Pain Than Bupivacaine and Added Buprenorphine in Patients Undergoing Same-day Discharge Total Knee Arthroplasty?

NCT05091138 | Unknown

• 1 other identifier: Mg versus Buprenorphine in TKA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery

  Measuring the post surgical total opioid consumption in the first 24 hours after surgery by calculating oral morphine equivalents (mg)

  The first 24 hours after surgery

• Total opioid consumption (oral morphine equivalents) in the second 24 hours after surgery

  Measuring the post surgical total opioid consumption in the second 24 hours after surgery by calculating oral morphine equivalents (mg)

  The second 24 hours after surgery

• Visual analog scale (VAS) pain score at 24 hours after surgery

  Determining pain scores using Visual analog scale (VAS) at 24 hours after surgery (0-10, Higher scores mean worse outcome)

  24 hours after surgery

• Visual analog scale (VAS) pain score at 48 hours after surgery

  Determining pain scores using Visual analog scale (VAS) at 48 hours after surgery (0-10, Higher scores mean worse outcome)

  48 hours after surgery

Secondary Outcomes (2)

• Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery

  First 48 hours after surgery

• Overall patient satisfaction in first 48 hours after surgery

  First 48 hours after surgery

Study Arms (2)

Mg and Bupivacaine

ACTIVE COMPARATOR

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.

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

Buprenorphine and Bupivacaine

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Mg and Bupivacaine

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

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.

Buprenorphine and Bupivacaine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Sandeep Krishnan, M.D.

CONTACT

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

Farhad Ghoddoussi, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: October 12, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)