Amount of pain reduction after a nerve block with 5 mL of bupivacaine 0.25% and 10 mL of Exparel® (133 mg) versus 15 mL of 0.25% bupivacaine after arthroscopic shoulder surgery

Phase 1

• Conditions: Postoperative pain after arthroscopic shoulder surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-001559-55-BE
• Lead Sponsor: Ziekenhuis Oost-Limburg, Departement of Anesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-30
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

?Dutch or English speaking adults
?18 years or older ASA I-III physical class
?Scheduled for elective arthroscopic shoulder surgery

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

?History of allergy to a local anesthetic
?Baseline neurological deficit
?Medical condition that would make it difficult to assess sensory distribution or communicate with our staff
?Recent history (< 3 months) of drug or alcohol abuse
?Concomitant opioid therapy
?Preexisting coagulation disorder
?Infection at the injection site
?Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified