Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair
RCR
Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Arthroscopic Rotator Cuff Repair Surgery: A Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to compare pain control after arthroscopic rotator cuff repair surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedStudy Start
First participant enrolled
July 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2021
CompletedResults Posted
Study results publicly available
July 27, 2022
CompletedJuly 27, 2022
July 1, 2022
2.8 years
June 20, 2018
March 3, 2022
July 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Total Intraoperative Opioids Used
Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.
through end of surgery
Study Arms (2)
liposomal bupivacaine
EXPERIMENTALThese patients receive an interscalene block with liposomal bupivacaine.
bupivacaine
ACTIVE COMPARATORThese patients receive an interscalene block with bupivacaine.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients aged greater than 18 years of age that are undergoing arthroscopic rotator cuff surgery
You may not qualify if:
- Patients with allergy to local anesthetics
- Patients with daily use of opioids for more than 3 weeks prior to surgery
- Patients who refuse
- Patients with coagulopathy
- Patients who are non-english speaking
- Patients who do not have access to a telephone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Flaherty JM, Berg AA, Harrison A, Braman J, Pearson JM, Matelich B, Kaizer AM, Hutchins JL. Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial. Reg Anesth Pain Med. 2022 May;47(5):309-312. doi: 10.1136/rapm-2021-103349. Epub 2022 Feb 21.
PMID: 35190468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aaron Berg
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Tenzin Desa
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 16, 2018
Study Start
July 25, 2018
Primary Completion
May 25, 2021
Study Completion
June 8, 2021
Last Updated
July 27, 2022
Results First Posted
July 27, 2022
Record last verified: 2022-07