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Dexamethasone and Lower Extremity Block Duration

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ClinicalTrials.gov Identifier: NCT01756586
Recruitment Status : Terminated (no logistical support to carry out the study fairly)
First Posted : December 27, 2012
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.

Condition or disease Intervention/treatment Phase
Analgesia Duration Drug: Dexamethasone Drug: Bupivacaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
Plain bupivacaine
Drug: Bupivacaine
Control
Experimental: Experimental
Bupivacaine with Dexamethasone
Drug: Dexamethasone Drug: Bupivacaine
Control



Primary Outcome Measures :
  1. Increase in the Duration of Block [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75
  2. foot surgery
  3. no contraindication to regional anesthesia

Exclusion Criteria:

  1. opioid dependent
  2. chronic pain condition
  3. peripheral neuropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756586


Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01756586     History of Changes
Other Study ID Numbers: IRB12-2198
First Posted: December 27, 2012    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017

Keywords provided by University of Chicago:
popliteal block
analgesia duration

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Bupivacaine
BB 1101
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