NCT00801138

The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.

Detailed description

This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. 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 analgesic request after PACU discharge. Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.

Conditions

• Anesthesia, Local
• Shoulder Surgery

Interventions

Type	Name	Description
DRUG	saline	2 ml 0.9% saline (placebo)
DRUG	Dexamethasone	dexamethasone 8 mg (2 ml)
DRUG	ropivacaine	30 ml 0.5% ropivacaine
DRUG	Bupivacaine	30 ml 0.5% bupivacaine

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-12-03
• Last updated: 2017-05-01
• Results posted: 2017-05-01

Locations

1 site across 1 country: United States