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

Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00801138
• Other study ID #: 08-647
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 2, 2008
• Last updated: February 17, 2011
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 218
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 75 years

• Patients undergoing shoulder procedures such as rotator cuff repair capsular shift shoulder arthroplasty subacromial decompression

Exclusion Criteria:

• Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)

• Pregnancy

• Preexisting neuropathy involving the surgical limb

• Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery

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

• Shoulder Surgery

Intervention

Drug:
• Ropivacaine

• Bupivacaine

• Dexamethasone
steroid
• Placebo
saline

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the duration of the interscalene nerve block which is time to first administration of pain medication after block		Post op days 1,2 and 3 and 14 days after surgery	No
Secondary	These include time to a significant increase in shoulder discomfort, time to a noticeable decrease in numbness and/or weakness, maximum VRS with rest and movement, and total opioid consumption.		Post op days 1,2 and 3 and 14 days after surgery	No