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Measuring Opioid Use After Rotator Cuff Repair: Comparing the Effects of Standard vs. Extended-release Nerve Blocks

NCT05482113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-08-01

No results posted yet for this study

Summary

The investigators aim to determine if a longer acting nerve block, which is a local anesthetic, can help reduce opioid use after surgery in patients that are getting rotator cuff repair surgery. The investigators will also determine if the longer acting block can reduce the number of days that opioids are taken after surgery. Patients that schedule this type of surgery will be given information regarding the study and asked if they want to participate. If they do, they will be randomized to either receive the standard nerve block or the longer acting nerve block. Participants and physicians will not know which nerve block the participants are receiving. Participants will receive a standard pain medication prescription after surgery and will be asked to record pain scores, medications taken and satisfaction level every day in a journal for two weeks. Participants will be asked to bring in their medication bottles and pain journal to the 2-week follow up appointment. Participants' pain scores will be assessed in the office at the follow up appointment and study staff will conduct a pill count. Participants will return for a 6-week follow up appointment and pain scores will be assessed again at that time, and another pill count will be conducted. At this point the study will be complete.

Conditions

  • Rotator Cuff Tears

Interventions

DRUG

Liposomal bupivacaine

Liposomal Bupivacaine (Exparel) Brachial Plexus Block for Arthroscopic Rotator Cuff Repair

DRUG

Bupivacaine Hcl 0.25% Inj

Standard 0.25% Bupivacaine Brachial Plexus Block for Arthroscopic Rotator Cuff Repair

Sponsors & Collaborators

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Thomas K Miller, MD · Section Chief, Sports Medicine, Carilion Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2021-12-15
Completion
2021-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482113 on ClinicalTrials.gov