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

This study has been terminated.
(A strong primary outcome crosses the efficacy boundary at the interim analysis)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00801138
First received: December 2, 2008
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Anesthesia, Local
Shoulder Surgery
Drug: saline
Drug: Dexamethasone
Drug: ropivacaine
Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block [ Time Frame: Postoperative day 1, 2 and 3 ]

Secondary Outcome Measures:
  • Time to First Report of Pain [ Time Frame: Postoperative day 1, 2 and 3 ]
  • Median Maximum VAS Pain Scores at Rest [ Time Frame: Postoperative day 1, 2 and 3 ]
    Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates"no pain at all" and ten indicates "worst pain imaginable." , The higher of the score, the worse of the pain.

  • Total Three-day Opioid Consumption in Oral Oxycodone Equivalent [ Time Frame: Postoperative day 1, 2 and 3 ]

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: saline
2 ml 0.9% saline (placebo)
Drug: ropivacaine
30 ml 0.5% ropivacaine
Placebo Comparator: Group 2
Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Drug: saline
2 ml 0.9% saline (placebo)
Drug: Bupivacaine
30 ml 0.5% bupivacaine
Active Comparator: Group 3
Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)
Drug: Dexamethasone
dexamethasone 8 mg (2 ml)
Drug: ropivacaine
30 ml 0.5% ropivacaine
Active Comparator: Group 4
Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).
Drug: Dexamethasone
dexamethasone 8 mg (2 ml)
Drug: Bupivacaine
30 ml 0.5% bupivacaine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Pre-existing neuropathy involving the surgical limb
  • Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
  • Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The Cleveland Clinic
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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00801138     History of Changes
Other Study ID Numbers: 08-647
Study First Received: December 2, 2008
Results First Received: July 18, 2016
Last Updated: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
ropivacaine
bupivacaine
glucocorticoid

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

ClinicalTrials.gov processed this record on May 25, 2017