Adductor Canal Blocks With Bupivacaine and Magnesium After Same-day Discharge Total Knee Arthroplasty Improve Post-operative Pain Relief and Decrease Opioid Consumption: a Prospective Randomized Controlled Trial

NCT05004636 | Completed

• 1 other identifier: Mg_in_TKA
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks (ACB) can decrease opioid consumption and improve pain management for patients after same-day discharge total knee arthroplasty (TKA). The investigators will assess whether the addition of magnesium 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 magnesium is not administered.

Conditions

Post-operative Pain, Acute

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)

No_Mg

NO INTERVENTION

Ctrl Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will not receive Mg (the intervention) in the block; instead they will receive 0.3mL of sterile saline.

Mg

EXPERIMENTAL

Treatment Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will receive 150 mg Mg (0.3 mL-the intervention) in the block.

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

Interventions

Adding Magnesium as an adjuvant to 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 (0.3mL) in the block and the other half will receive 0.3 mL of saline in the block.

Mg

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

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Sandeep Krishnan, MD

  Wayne State University School of Medicine Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

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: Clinical Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 13, 2021
• Study Start: August 5, 2020
• Primary Completion: May 29, 2021
• Study Completion: May 29, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)