Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL)

September 24, 2019 updated by: Metaxia Bareka, Larissa University Hospital

Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.

Study Overview

Study Type

Interventional

Enrollment (Actual)

106

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

    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Larissa University Hospital

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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-50 years old
  • ASA I - II
  • ACL reconstruction surgery

Exclusion Criteria:

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurologic deficit in the arm that is going to be operated
  • Allergy to local anesthetics
  • BMI > 35
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACL, sciatic, femoral, obturator
ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Ultrasound guided blocks with ropivacaine
Active Comparator: ACL, sciatic nerve block, posterior lumbar plexus block
ACL reconstruction surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block
Ultrasound and neurostimulator nerve blocks with ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale
Time Frame: 45 min
If the patient complains for pain > 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask
45 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Time Frame: Intraoperatively
Intraoperatively
Postoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Time Frame: 24h
24h

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Metaxia Bareka, Medicine, Larissa University Hospital
  • Study Chair: Marina Simaioforidou, Medicine, Larissa University Hospital
  • Study Director: George Vretzakis, Medicine, Larissa University Hospital
  • Study Chair: Eleni Chantzi, Medicine, Larissa University Hospital
  • Study Chair: Michael Hantes, Medicine, Larissa University Hospital
  • Study Chair: Eleni Askitopoulou, Medicine, Heraklion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

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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