Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Analgesia Clinical Trial

Official title:

Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974385
• Other study ID #: HSR210190
• Status: Completed
• Phase: Phase 3
• Start date: August 4, 2021
• Est. completion date: May 4, 2022

Study information

• Verified date: November 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 4, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Liposomal bupivacaine
Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.
• Bupivacaine
Active comparator as standard of care.

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Morphine equivalents used during first 72 hours after surgery	72 hours postoperative
Secondary	Numeric Rating Scale Reported Pain Scores	Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain	72 hours postoperative
Secondary	Nerve Block Related Adverse Events	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.	72 hours postoperative
Secondary	Patients with Additional, Unanticipated Pain Related Medical Encounters	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	72 hours postoperative
Secondary	Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale	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	72 hours postoperative