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

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:
NCT01756560
First received: December 20, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

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:

  • 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: 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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01756560     History of Changes
Other Study ID Numbers: IRB12-2191
Study First Received: December 20, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System 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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on September 18, 2014