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Prospective Evaluation of Femoral Versus Femoral and Sciatic Nerve Block for Ambulatory Anterior Cruciate Ligament (ACL) Reconstruction

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ClinicalTrials.gov Identifier: NCT01447277
Recruitment Status : Unknown
Verified May 2013 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : October 6, 2011
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, post operative nausea/vomiting, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Procedure: Sciatic Block Procedure: Femoral Block only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Femoral and Sciatic Block Procedure: Sciatic Block
Performing a sciatic block in addition to a femoral block preoperatively
Femoral Block Only Procedure: Femoral Block only
Performing a preoperative sciatic nerve block only


Outcome Measures
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Primary Outcome Measures :
  1. Pain Scores [ Time Frame: Duration of stay at recovery room unil post operative day number 3. ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Duration of stay in the recovery room ]
  2. Opiate consumption [ Time Frame: During surgery, recovery room and for 3 days after discharge ]
  3. PONV [ Time Frame: During the recovery room stay and after discharge from surgery center for up to 3 days. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and over
  • ASA status I-II
  • Scheduled for ambulatory Arthroscopic ACL Surgery

Exclusion Criteria:

  • Allergy to Local anesthetics or opiates used in the study
  • Contraindications for regional anesthesia
  • coagulopathy, anticoagulation, Thrombocytopenia
  • infection at site of injection
  • Chronic pain and high preoperative opiate requirements
  • High risk for PONV
Contacts and Locations
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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): NCT01447277


Contacts
Contact: Pedram Aleshi, MD 415-514-3757 aleship@anesthesia.ucsf.edu

Locations
United States, California
UCSF Orthopedic Institute Recruiting
San Francisco, California, United States
Contact: Pedram Aleshi, MD    415-514-6080    aleship@anesthesia.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01447277     History of Changes
Other Study ID Numbers: 11-06776
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by University of California, San Francisco:
ACL reconstruction
Femoral Block
Sciatic Block