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

NCT04180943 | Completed Phase 4 FDA Drug

• 1 other identifier: 1422773
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Time to first post-operative pain medication consumption in minutes from discharge from OR

  time to first post-operative pain medication

  72 hours

Secondary Outcomes (4)

• Worst daily post-op pain on a scale 1-10

  72 hours

• Least daily post-op pain on a scale 1-10

  72 hours

• Average daily post-op pain on a scale 1-10

  72 hours

• Total opioid use in morphine equivalents in the first 72 hours post-op

  72 hours

Study Arms (2)

liposomal bupivicaine

ACTIVE COMPARATOR

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

bupivicaine

ACTIVE COMPARATOR

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

Interventions

interscalene nerve block DRUG

intra and post-operative analgesia

Also known as: liposomal bupivicaine

bupivicaine; liposomal bupivicaine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

Study Officials

• Linda Demma, MD, PhD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician - anesthesiology

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: December 13, 2019
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)