Text Size

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

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01447277
First received: September 30, 2011
Last updated: May 16, 2013
Last verified: May 2013
History of Changes

September 30, 2011
May 16, 2013
October 2011
October 2013   (final data collection date for primary outcome measure)
Pain Scores [ Time Frame: Duration of stay at recovery room unil post operative day number 3. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01447277 on ClinicalTrials.gov Archive Site
  • Length of stay [ Time Frame: Duration of stay in the recovery room ] [ Designated as safety issue: No ]
  • Opiate consumption [ Time Frame: During surgery, recovery room and for 3 days after discharge ] [ Designated as safety issue: No ]
  • PONV [ Time Frame: During the recovery room stay and after discharge from surgery center for up to 3 days. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of Femoral Versus Femoral and Sciatic Nerve Block for Ambulatory Anterior Cruciate Ligament (ACL) Reconstruction
The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anterior Cruciate Ligament Reconstruction
  • Procedure: Sciatic Block
    Performing a sciatic block in addition to a femoral block preoperatively
  • Procedure: Femoral Block only
    Performing a preoperative sciatic nerve block only
  • Experimental: Femoral and Sciatic Block
    Intervention: Procedure: Sciatic Block
  • Femoral Block Only
    Intervention: Procedure: Femoral Block only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pedram Aleshi, MD 415-514-3757 aleship@anesthesia.ucsf.edu
United States
 
NCT01447277
11-06776
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Not Provided
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP