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NCT Number: NCT07614802

Exparel 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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Arthroscopic Surgeries Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Dexamethasone

Drug

6 mg preservative-free dexamethasone

Primary outcomes

  1. time until resolution of sensory block

    Time frame: 0-10 days

    Patients will be called daily until resolution of their sensory block

Secondary outcomes

  1. duration of motor blockade

    Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively

  2. pain scores (scale of 0-10)

    Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively

    Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable

  3. opioid consumption (in oral morphine equivalents)

    Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively

  4. known side effects of interscalene blocks

    Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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