Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Phase 4

Completed

• Conditions: Pain, Postoperative; Brachial Plexus Block
• Interventions: Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj; Drug: Bupivacaine HCl

• Registration Number: NCT05005260
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-13
• Study Start: 2021-10-14
• Primary Completion: 2023-03-18
• Study Completion: 2023-03-18
• Results First Submitted: 2023-11-05
• Results First Submitted QC: 2023-12-15
• Results First Posted: 2023-12-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liposomal bupivacaine single-shot interscalene blockade	Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj	Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
continuous interscalene nerve blockade	Bupivacaine HCl	Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Primary Outcome Measures

Name	Time	Method
Pain Intensity Score at Rest at 24 Hours Post-operatively	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 Outcome Measures

Name	Time	Method
Cumulative Opioid Consumption	PACU to postoperative day 3	Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3
Quality of Recovery Score (QoR)	Post-Operative Day 1	15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States