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?

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Post-operative Pain, Acute
• Intervention / Treatment: Drug: Adding Magnesium as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty; Drug: Adding Buprenorphine as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty

Detailed Description

Total knee arthroplasty (TKA) is one of the most common elective surgical procedures in the United States . The number of TKA procedures has doubled in each of the past two decades and is expected to top 3.4 million per year in the United States by 2030.

Within the last 10-15 years significant changes have taken place in the anesthetic management of patients undergoing total knee arthroplasty (TKA). In the past, the majority of patients underwent general anesthesia and were managed post-operatively with a PCA (patient controlled analgesia) pump.

More recently anesthesiologists have begun to use neuraxial anesthesia (spinal anesthesia) combined with regional anesthesia (peripheral nerve block (PNB)) techniques combined with monitored anesthesia care (MAC) for many of these surgeries.

Regional anesthesia is used to block the sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.

However, the duration of traditional amide-based and ester-based regional anesthesia is normally limited to only a few hours. Techniques including continuous catheter placement or serial injections can be used to enhance the duration and effect of regional anesthesia for postoperative pain control. But these approaches can increase the risk of infection, toxicity, and cost. Therefore, alternative methods of extending the clinical duration of nerve blocks have been a topic of significant interest.

The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks can decrease opioid consumption and improve pain management for patients after total knee arthroplasty (TKA) versus adding buprenorphine to bupivacaine for the blocks.

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 buprenorphine is administered instead.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandeep Krishnan, M.D.; Phone Number: (248) 858-6068; Email: sakrishna@med.wayne.edu
• Study Contact Backup: Name: Farhad Ghoddoussi, Ph.D.; Phone Number: (248) 858-6068; Email: fghoddoussi@med.wayne.edu

Study Locations

• United States
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • Recruiting
      • St. Joseph Mercy Oakland Hospital
      • Contact: Lena Anderson; Phone Number: 248-858-6068; Email: LeAnders@med.wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.
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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery	The incidence of nausea or vomiting in the first 48 hours after surgery is recorded	First 48 hours after surgery
Overall patient satisfaction in first 48 hours after surgery	Patient satisfaction scores averaged over the first 48 hours after surgery (0-10, higher scores are better)	First 48 hours after surgery

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Same-day discharge total knee arthroplasty; Magnesium; Adductor canal block; Post-operative opioid consumption; Post-operative pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Anesthetics, Local; Buprenorphine; Bupivacaine
• Other Study ID Numbers: Mg versus Buprenorphine in TKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No