Dexamethasone and Block Duration in Upper Extremity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01756573
First received: December 20, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

Effect of dexamethasone on prolonging upper extremity block is well known. But it not known if the effect comes from its local effect on the nerves or from its general analgesic effect. In this study we will compare the systemic effect to its local effect to find out if there is a difference or not.


Condition Intervention Phase
Duration of Pain Relief
Drug: Dexamthsone
Drug: Bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Effect of Dexamethasone on Duration of Upper Extremity Blocks With Bupivacaine

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • analgesia duration [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine
Control
Drug: Bupivacaine
Experimental: Bupivacaine with Dexamethasone
Dexamethasone will be mixed with bupivacaine
Drug: Dexamthsone Drug: Bupivacaine
Active Comparator: Intravenous Dexamethasone
Dexamethasone will be given intravenously
Drug: Dexamthsone Drug: Bupivacaine

  Eligibility

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

Inclusion Criteria:

  • age 18-75, no contraindication to regional anesthesia,

Exclusion Criteria:

  • opioid user, chronic pain conditions, peripheral neuropathy
  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: NCT01756573

Contacts
Contact: Tariq Malik tmalik@dacc.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Tariq Malik, MD         
Sponsors and Collaborators
University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01756573     History of Changes
Other Study ID Numbers: IRB12-2192
Study First Received: December 20, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
block duration
analgesia

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

ClinicalTrials.gov processed this record on October 20, 2014