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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Anterior Cruciate Ligament Reconstruction
Procedure: Sciatic Block
Procedure: Femoral Block only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pain Scores [ Time Frame: Duration of stay at recovery room unil post operative day number 3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01447277     History of Changes
Other Study ID Numbers: 11-06776
Study First Received: September 30, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 25, 2014