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Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by University of Chicago.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756560
First Posted: December 27, 2012
Last Update Posted: March 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • analgesia duration [ Time Frame: 72 hours ]

Estimated Enrollment: 40
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: control
in this group, plain bupivacaine will be used to block femoral and sciatic nerve
Drug: Bupivacaine
Experimental: Dexamethasone
Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve
Drug: dexamethsone Drug: Bupivacaine

  Eligibility

Information from the National Library of Medicine

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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:

  • age 18-75, no contraindication to regional anesthesia

Exclusion Criteria:

  • peripheral neuropathy
  Contacts and Locations
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): NCT01756560


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

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Tariq Malik       tmalik@dacc.uchicago.edu   
Sponsors and Collaborators
University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01756560     History of Changes
Other Study ID Numbers: IRB12-2191
First Submitted: December 20, 2012
First Posted: December 27, 2012
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by University of Chicago:
anterior cruciate ligament
block duration

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
BB 1101
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


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