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

This study has been terminated.
(Based on a strong primary outcome (prolonged analgesia with dexamethasone) and futility for type of local anesthetic, study was terminated.)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00801138
First received: December 2, 2008
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Shoulder Surgery
 Drug: Ropivacaine
Drug: Bupivacaine
Drug: Dexamethasone
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • The primary outcome is the duration of the interscalene nerve block which is time to first administration of pain medication after block [ Time Frame: Post op days 1,2 and 3 and 14 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Post op days 1,2 and 3 and 14 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
 Drug: Ropivacaine Drug: Placebo
saline
Placebo Comparator: Group 2
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
 Drug: Bupivacaine Drug: Placebo
saline
Active Comparator: Group 3

Group 3 Ropivacaine and dexamethasone:

Ropivacaine plus dexamethasone

 Drug: Ropivacaine Drug: Dexamethasone
steroid
Active Comparator: Group 4

Group 4 Bupivacaine and steroid:

Bupivacaine plus dexamethasone

 Drug: Bupivacaine Drug: Dexamethasone
steroid

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801138

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Study Director: Ivan Parra Sanchez, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Kenneth Cummings, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00801138     History of Changes
Other Study ID Numbers: 08-647
Study First Received: December 2, 2008
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
interscalene nerve block
analgesia

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013