Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Sponsor

University of Virginia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04974385

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Liposomal bupivacaine Drug: Bupivacaine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 4, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal Bupivacaine Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.	Drug: Liposomal bupivacaine Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty. Other Names: Exparel Drug: Bupivacaine Active comparator as standard of care.
Active Comparator: Non-liposomal Bupivacaine Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine	Drug: Bupivacaine Active comparator as standard of care.

Arm

Intervention/Treatment

Experimental: Liposomal Bupivacaine

Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.

Drug: Liposomal bupivacaine

Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.

Other Names:

Exparel

Drug: Bupivacaine

Active comparator as standard of care.

Active Comparator: Non-liposomal Bupivacaine

Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine

Drug: Bupivacaine

Active comparator as standard of care.

Outcome Measures

Primary Outcome Measures

Opioid Consumption [72 hours postoperative]
Morphine equivalents used during first 72 hours after surgery

Secondary Outcome Measures

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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Medical Center	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

University of Virginia

Investigators

Principal Investigator: Donald A Elmer, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

D. Aric Elmer, MD, Principal Investigator, University of Virginia

ClinicalTrials.gov Identifier:

NCT04974385

Other Study ID Numbers:

HSR210190

First Posted:

Jul 23, 2021

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of May 18, 2022