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

Primary Purpose

Anterior Cruciate Ligament Tear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sciatic Block
Femoral Block only
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring ACL reconstruction, Femoral Block, Sciatic Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Orthopedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Femoral and Sciatic Block

Femoral Block Only

Arm Description

Administration of preoperative femoral and sciatic nerve blocks

Administration of a femoral nerve block prior to surgery

Outcomes

Primary Outcome Measures

Pain Scores

Secondary Outcome Measures

Length of stay
Opiate consumption
PONV

Full Information

First Posted
September 30, 2011
Last Updated
February 20, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01447277
Brief Title
Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
Keywords
ACL reconstruction, Femoral Block, Sciatic Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral and Sciatic Block
Arm Type
Experimental
Arm Description
Administration of preoperative femoral and sciatic nerve blocks
Arm Title
Femoral Block Only
Arm Type
Other
Arm Description
Administration of a femoral nerve block prior to surgery
Intervention Type
Procedure
Intervention Name(s)
Sciatic Block
Intervention Description
Performing a sciatic block in addition to a femoral block preoperatively
Intervention Type
Procedure
Intervention Name(s)
Femoral Block only
Intervention Description
Performing a preoperative sciatic nerve block only
Primary Outcome Measure Information:
Title
Pain Scores
Time Frame
PACU and POD1, 2 and 3.
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
Duration of stay in the recovery room
Title
Opiate consumption
Time Frame
During surgery, recovery room and for 3 days after discharge
Title
PONV
Time Frame
During the recovery room stay and after discharge from surgery center for up to 3 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCSF Orthopedic Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

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

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