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Clinical Trials/NCT05005260
NCT05005260
Completed
Phase 4

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

Mayo Clinic1 site in 1 country88 target enrollmentOctober 14, 2021

Overview

Phase
Phase 4
Intervention
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
Conditions
Pain, Postoperative
Sponsor
Mayo Clinic
Enrollment
88
Locations
1
Primary Endpoint
Pain Intensity Score at Rest at 24 Hours Post-operatively
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Registry
clinicaltrials.gov
Start Date
October 14, 2021
End Date
March 18, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason K. Panchamia, D.O.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

liposomal bupivacaine single-shot interscalene blockade

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Intervention: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

continuous interscalene nerve blockade

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Intervention: Bupivacaine HCl

Outcomes

Primary Outcomes

Pain Intensity Score at Rest at 24 Hours Post-operatively

Time Frame: Post-Operative Day 1

Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.

Secondary Outcomes

  • Cumulative Opioid Consumption(PACU to postoperative day 3)
  • Quality of Recovery Score (QoR)(Post-Operative Day 1)

Study Sites (1)

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