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Clinical Trial Summary

This study will test the hypothesis that the effect of dexamethasone on the analgesic duration of interscalene nerve blocks differs between ropivacaine and bupivacaine. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.


Clinical Trial Description

This is a randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. The study will investigate the effect of dexamethasone on analgesic duration. Participants will be randomized into one of four groups:

- Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;

- Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);

- Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;

- Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.

The primary outcome is the duration of the interscalene nerve block which is time to first administration of pain medication after block

A blinded observer will interview patients each morning for three days postoperatively, either in the hospital or by telephone and at 14 days post operatively. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00801138
Study type Interventional
Source Outcomes Research Consortium
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date November 2008
Completion date November 2010

See also
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