Exparel and Dexamethasone

The Power Couple of Regional Analgesia? A Prospective Randomized Controlled Trial Comparing Block Duration With Liposomal Bupivacaine and Dexamethasone

This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Shoulder Arthroscopic Surgeries
• Intervention / Treatment: Drug: Liposomal Bupivacaine with Bupivacaine; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 18 to 80 years
2. ASA physical status 1-3
3. Undergoing primary shoulder surgery with interscalene nerve block

Exclusion Criteria:

1. ASA 4 or 5
2. Revision shoulder surgery
3. Daily chronic opioid use (over 3 months of continuous opioid use)
4. Inability to communicate pain scores or need for analgesia
5. Infection at the site of block placement
6. Age under 18 years old or greater than 80 years old
7. Pregnant women (as determined by point-of-care serum bHCG)
8. Intolerance/allergy to local anesthetics
9. Weight <50 kg
10. BMI > 40
11. severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
12. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
14. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal Bupivacaine Alone; Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine. This regimen represents standard of care for prolonged regional analgesia in shoulder surgery.	Drug: Liposomal Bupivacaine with Bupivacaine; Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery.
Experimental: Liposomal Bupivacaine + Dexamethasone; Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine and 6 mg preservative-free dexamethasone. This arm evaluates whether the addition of dexamethasone prolongs sensory blockade duration compared to liposomal bupivacaine alone.	Drug: Liposomal Bupivacaine with Bupivacaine; Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery.; Drug: Dexamethasone; 6 mg preservative-free dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until resolution of sensory block	Patients will be called daily until resolution of their sensory block	0-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of motor blockade		2, 12, 24, 36, 48, 72, and 96 hours postoperatively
opioid consumption (in oral morphine equivalents)		2, 12, 24, 36, 48, 72, and 96 hours postoperatively
known side effects of interscalene blocks		2, 12, 24, 36, 48, 72, and 96 hours postoperatively
pain scores (scale of 0-10)	Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable	2, 12, 24, 36, 48, 72, and 96 hours postoperatively

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Emily Hall, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; Bupivacaine
• Other Study ID Numbers: PRO00119364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No