Study to desribe the processing of bupivacaine in the body when Exparel is injected around the nerves in the neck for pain treatment in total shoulder replacement.

• Conditions: patients receiving a primary total shoulder arthroplasty; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002402-36-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-29
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age =18 years
-ASA physical health classification I-II
-Patient planned for a primary unilateral total shoulder arthroplasty or reversed shoulder arthroplasty under total anesthesia with a locoregional anesthetic block
-Hb >7.5 mmol/L
-Written informed consent

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-BMI (body mass index) >35kg/m2
-Known hypersensitivity to amide-type local anesthetics
-Chronic use of opiates
-Contraindication for paracetamol, NSAID’s or opiates.
-COPD gold 3-4 or any other pulmonary disease that significantly affects pulmonary function
-Hepatic or renal insufficiency
-Use of fluvoxamine, ciproflocaxine, ketoconazol, erytromycine, claritromycine, itraconazol or rifampicine because of their effect on bupivacaine clearance.
-Inadequate proficiency in Dutch.
-Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Study & Design

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