Exparel and Dexamethasone

NCT07614802 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00119364
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Shoulder Arthroscopic Surgeries

Outcome Measures

Primary Outcomes (1)

• time until resolution of sensory block

  Patients will be called daily until resolution of their sensory block

  0-10 days

Secondary Outcomes (4)

• duration of motor blockade

  2, 12, 24, 36, 48, 72, and 96 hours postoperatively

• pain scores (scale of 0-10)

  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

Study Arms (2)

Liposomal Bupivacaine Alone

ACTIVE COMPARATOR

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

Liposomal Bupivacaine + Dexamethasone

EXPERIMENTAL

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; Drug: Dexamethasone

Interventions

Dexamethasone DRUG

6 mg preservative-free dexamethasone

Liposomal Bupivacaine + Dexamethasone

Liposomal Bupivacaine with Bupivacaine DRUG

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.

Liposomal Bupivacaine + Dexamethasone; Liposomal Bupivacaine Alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA 4 or 5
• Revision shoulder surgery
• Daily chronic opioid use (over 3 months of continuous opioid use)
• Inability to communicate pain scores or need for analgesia
• Infection at the site of block placement
• Age under 18 years old or greater than 80 years old
• Pregnant women (as determined by point-of-care serum bHCG)
• Intolerance/allergy to local anesthetics
• Weight \<50 kg
• BMI \> 40
• severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
• Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Emily Hall

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Provider given care is not preparing study drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share