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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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.


Description:

Although femoral nerve blocks improve analgesia after anterior cruciate ligament (ACL) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. In a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory ACL reconstruction. We hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter PACU length of stay and improved patient satisfaction.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sciatic Block
Performing a sciatic block in addition to a femoral block preoperatively
Femoral Block only
Performing a preoperative sciatic nerve block only

Locations

Country Name City State
United States UCSF Orthopedic Institute San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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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