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

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ClinicalTrials.gov Identifier: NCT01447277
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Procedure: Sciatic Block Procedure: Femoral Block only Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Femoral and Sciatic Block
Administration of preoperative femoral and sciatic nerve blocks
 Procedure: Sciatic Block
Performing a sciatic block in addition to a femoral block preoperatively
Femoral Block Only
Administration of a femoral nerve block prior to surgery
 Procedure: Femoral Block only
Performing a preoperative sciatic nerve block only


Outcome Measures
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Primary Outcome Measures :
  1. Pain Scores [ Time Frame: PACU and POD1, 2 and 3. ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Duration of stay in the recovery room ]
  2. Opiate consumption [ Time Frame: During surgery, recovery room and for 3 days after discharge ]
  3. PONV [ Time Frame: During the recovery room stay and after discharge from surgery center for up to 3 days. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447277


Locations
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United States, California
UCSF Orthopedic Institute
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01447277    
Other Study ID Numbers: 11-06776
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Keywords provided by University of California, San Francisco:
ACL reconstruction
Femoral Block
Sciatic Block
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries