Liposomal Bupivacaine Versus Bupivacaine for for Postoperative Pain Control in Shoulder Surgery

Liposomal Bupivacaine Versus Bupivacaine for Interscalene Nerve Block for Postoperative Pain Control in Shoulder Arthroplasty/Arthroscopy: a Prospective Randomized Controlled Trial

This is a randomized, single blinded clinical trial whose purpose is to assess the impact of liposomal bupivacaine (LB) in a single shot interscalene nerve block compared with standard bupivacaine (same dose) in a single shot interscalene nerve block in terms of postoperative pain control. Specifically, outpatient pain scores,use of postoperative pain medicine and patient-reported functional outcomes after shoulder arthroplasty surgery will be evaluated.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: interscalene nerve block

Detailed Description

Background:

Shoulder arthroplasty is the fastest growing joint replacement surgery in the United States, and optimal postoperative pain management is critical to optimize outcomes for these surgeries. LB has gained popularity for its potential to provide extended postoperative pain relief with possibly fewer side effects. LB (Exparel, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA) has recently gained popularity for its potential to provide extended postoperative pain relief and was recently approved by the FDA for use in interscalene nerve blocks. Several studies have investigated its efficacy after hip and knee arthroplasty and demonstrated efficacy with decreased opioid consumption, early mobilization, lower hospital costs, and shorter length of stay for patients undergoing surgeries such as bunionectomy, open colectomy, umbilical hernia repair, breast augmentation, and total knee arthroplasty. Limited studies have evaluated the efficacy of LB for perioperative pain control in shoulder arthroplasty. Hence, the objective of this study is to determine whether the use of an LB-based multimodal analgesic regimen provides better postoperative pain control and patient satisfaction, greater cost effectiveness, and lower risk profile compared with standard bupivacaine in interscalene nerve bloc

Study Design and Methods:

This will be a prospective, randomized, single blinded, controlled clinical trial comparing patients undergoing shoulder arthroscopy and arthroplasty treated with LB versus standard bupivacaine with a single bolus interscalene block. The block administrator will not be blinded. The patient and the staff members conducting the follow up assessments, phone calls, and data collection will be blinded to treatment assignment. Study drug administrators (anesthesiologists) will not be blinded. There will be at least one unblinded study coordinator who will not be involved in collecting outcome data.

Patients will be randomized in 1:1 ratio to LB or standard bupivacaine with a single bolus interscalene block. Patient will receive the assigned interscalene block preoperatively per usual procedure. The primary outcome, time to first post operative pain medication will be recorded either from the medical record if administered in the hospital or via telephone assessment if consumed outside the hospital. Study staff will contact the patient by phone post op day (POD) 1, 2, and 3 to assess pain levels, pain medication consumption, sleep, and adverse events. The total participation time for each patient will be approximately four days (operative day and POD 1,2,3).

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• patients aged 18 years or older
• undergoing shoulder arthroscopy or arthroplasty
• must meet the criteria for standard of care of ambulatory surgery patients per anesthesia guidelines issued by the American Society of Anesthesiologists

Exclusion criteria:

• contraindications to regional anesthesia,
• allergy to any component of multimodal analgesia
• history of opioid use of >50 morphine milligram equivalents (MME) daily,
• significant peripheral neuropathy or neurologic disorder affecting the upper extremity,
• cognitive or psychiatric condition that might affect the patient?s assessment or inability to provide informed consent
• pregnancy (this is an exclusion for surgery as well)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: liposomal bupivicaine; interscalene nerve block using liposomal bupivacaine (Exaprel) 10 ml mixed with 0.5% bupivacaine in same syringe - volume of bupivacaine per MD based on pt weight, etc but CANNOT EXCEED 13mL	Drug: interscalene nerve block; intra and post-operative analgesia; Other Names: liposomal bupivicaine
Active Comparator: bupivicaine; interscalene block using standard bupivicaine (combination of ropivacaine 0.5% and lidocaine 2%) (volume per MD based on pt weight) + decadron	Drug: interscalene nerve block; intra and post-operative analgesia; Other Names: liposomal bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first post-operative pain medication consumption in minutes from discharge from OR	time to first post-operative pain medication	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst daily post-op pain on a scale 1-10	patient reported outcome of pain severity	72 hours
Least daily post-op pain on a scale 1-10	patient reported outcome of pain severity	72 hours
Average daily post-op pain on a scale 1-10	patient reported outcome of pain severity	72 hours
Total opioid use in morphine equivalents in the first 72 hours post-op	Total post-op opioid use	72 hours

Collaborators and Investigators

• Sponsor: Bassett Healthcare
• Investigators: Principal Investigator: Linda Demma, MD, PhD, Bassett Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1422773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be available to other researchers outside of the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes