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

February 20, 2020 updated by: University of California, San Francisco

The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Orthopedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: Femoral Block Only
Administration of a femoral nerve block prior to surgery
Procedure: Femoral Block only
Performing a preoperative sciatic nerve block only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores
Time Frame: PACU and POD1, 2 and 3.
PACU and POD1, 2 and 3.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-06776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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