Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Phase 3

Completed

• Conditions: Analgesia
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine

• Registration Number: NCT04974385
• Lead Sponsor: University of Virginia

Brief Summary

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-23
• Study Start: 2021-08-04
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adults 18 years of age or older
• Undergoing total shoulder arthroplasty
• Willing and able to sign consent form to participate in study

Exclusion Criteria

• < 18 years of age
• Unwilling or unable to sign consent form to participate in study
• Allergy to local anesthetic
• Medical contraindication to interscalene nerve block
• Chronic opioid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal bupivacaine	Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
Liposomal Bupivacaine	Bupivacaine	Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
Non-liposomal Bupivacaine	Bupivacaine	Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	72 hours postoperative	Morphine equivalents used during first 72 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale Reported Pain Scores	72 hours postoperative	Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain
Nerve Block Related Adverse Events	72 hours postoperative	Any adverse event determined to be caused as a result of having a nerve block to include but not limited to toxicity, allergic reaction, nerve injury.
Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale	72 hours postoperative	Patient reported satisfaction with their postoperative pain control using the numeric rating scale from 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied
Patients with Additional, Unanticipated Pain Related Medical Encounters	72 hours postoperative	Any unanticipated, unplanned, pain related phone calls to surgeon or anesthesiologist for rescue pain treatment, pain related emergency department visits or primary care physician visits for pain treatment

Trial Locations

Locations (1)

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States