Anterior Cruciate Ligament Tear Clinical Trial
Official title:
The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
| NCT number | NCT01447277 |
| Other study ID # | 11-06776 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2011 |
| Est. completion date | June 2013 |
| Verified date | February 2020 |
| Source | University of California, San Francisco |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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, 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.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | June 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UCSF Orthopedic Institute | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Francisco |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Scores | PACU and POD1, 2 and 3. | ||
| Secondary | Length of stay | Duration of stay in the recovery room | ||
| Secondary | Opiate consumption | During surgery, recovery room and for 3 days after discharge | ||
| Secondary | PONV | During the recovery room stay and after discharge from surgery center for up to 3 days. |
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