Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial.


Journal

Regional anesthesia and pain medicine
ISSN: 1532-8651
Titre abrégé: Reg Anesth Pain Med
Pays: England
ID NLM: 9804508

Informations de publication

Date de publication:
05 2022
Historique:
received: 23 11 2021
accepted: 02 02 2022
pubmed: 23 2 2022
medline: 22 4 2022
entrez: 22 2 2022
Statut: ppublish

Résumé

Single-injection interscalene brachial plexus blocks are used for analgesia for rotator cuff repair (RCR) but have limited duration. The value of adding liposomal bupivacaine (LB) to prolong single-injection interscalene blocks is unclear. The purpose of this trial is to evaluate the addition of LB to regular bupivacaine interscalene blocks for patients undergoing arthroscopic RCR. In this prospective, randomized trial, 70 patients undergoing primary RCR with equal group allocation were randomized by random number generator to receive an interscalene block with 20 mL of 0.5% bupivacaine or 10 mL 0.5% bupivacaine plus 133 mg LB. The primary outcome was cumulative opioid consumption within 72 hours of the procedure. Secondary outcomes included maximum pain scores and quality of recovery 15 survey scores. 70 of the 80 randomized patients were included in final analysis following exclusion for protocol violations and loss to follow-up. Cumulative opioid consumption (oral morphine equivalents) within 72 hours in patients receiving LB was a median (IQR) of 31.9 mg (0, 73.1) compared with 45.0 mg (15.0, 108.8) among patients receiving bupivacaine alone (p=0.312). Patients receiving LB demonstrated mixed results regarding worst pain scores with improvements at 24 hours and 72 hours, but not 48 hours. LB added to bupivacaine interscalene blocks does not reduce opioid consumption within 72 hours following arthroscopic RCR. NCT03587584.

Sections du résumé

BACKGROUND
Single-injection interscalene brachial plexus blocks are used for analgesia for rotator cuff repair (RCR) but have limited duration. The value of adding liposomal bupivacaine (LB) to prolong single-injection interscalene blocks is unclear. The purpose of this trial is to evaluate the addition of LB to regular bupivacaine interscalene blocks for patients undergoing arthroscopic RCR.
METHODS
In this prospective, randomized trial, 70 patients undergoing primary RCR with equal group allocation were randomized by random number generator to receive an interscalene block with 20 mL of 0.5% bupivacaine or 10 mL 0.5% bupivacaine plus 133 mg LB. The primary outcome was cumulative opioid consumption within 72 hours of the procedure. Secondary outcomes included maximum pain scores and quality of recovery 15 survey scores.
RESULTS
70 of the 80 randomized patients were included in final analysis following exclusion for protocol violations and loss to follow-up. Cumulative opioid consumption (oral morphine equivalents) within 72 hours in patients receiving LB was a median (IQR) of 31.9 mg (0, 73.1) compared with 45.0 mg (15.0, 108.8) among patients receiving bupivacaine alone (p=0.312). Patients receiving LB demonstrated mixed results regarding worst pain scores with improvements at 24 hours and 72 hours, but not 48 hours.
CONCLUSIONS
LB added to bupivacaine interscalene blocks does not reduce opioid consumption within 72 hours following arthroscopic RCR.
TRIAL REGISTRATION NUMBER
NCT03587584.

Identifiants

pubmed: 35190468
pii: rapm-2021-103349
doi: 10.1136/rapm-2021-103349
doi:

Substances chimiques

Analgesics, Opioid 0
Anesthetics, Local 0
Bupivacaine Y8335394RO

Banques de données

ClinicalTrials.gov
['NCT03587584']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

309-312

Informations de copyright

© American Society of Regional Anesthesia & Pain Medicine 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: JLH is a speaker, consultant, and has received research funds from Pacira Bioscience, he is a consultant and owns stock with Insitu Biologics, is a consultant and speaker for Acel RX, a consultant for Worrell, received research funds from Avanos, and was a consultant for Johnson and Johnson. AAB is a consultant for Pacira Bioscience.

Auteurs

James M Flaherty (JM)

Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA jflahert@umn.edu.

Aaron A Berg (AA)

Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.

Alicia Harrison (A)

Department of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA.

Jon Braman (J)

Department of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA.

Jonah M Pearson (JM)

Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.

Benjamin Matelich (B)

Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.

Alexander M Kaizer (AM)

Biostatistics and Informatics, School of Public Health Department of Biostatistics & Informatics, University of Colorado, Aurora, Colorado, USA.

Jacob L Hutchins (JL)

Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.

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Classifications MeSH