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:
University of California, San Francisco
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
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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
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 February 25, 2015