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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Metaxia Bareka, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01194505
First received: September 1, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament
Surgery
Other: Sciatic, femoral, obturator nerve blocks
Other: Sciatic nerve block, posterior lumbar plexus block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Intraoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
  • Postoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block [ Time Frame: 24h ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2010
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACL, sciatic, femoral, obturator
ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Other: Sciatic, femoral, obturator nerve blocks
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
Other: Sciatic nerve block, posterior lumbar plexus block
Ultrasound and neurostimulator nerve blocks with ropivacaine

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194505

Locations
Greece
Larissa University Hospital
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: Metaxia Bareka, 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
Study Chair: Marina Simaioforidou, Medicine Larissa University Hospital
  More Information

Publications:
Axel R Heller. Precision of Traditional Approaches for Lumbar Plexus Block. Anesthesiology 2009;111:525-32
Keßler J, Marhofer P, Rapp H, Hollmann MW. Ultraschallgezielte Anaesthesie peripheren Nerven. Anaesthesist 2007;56:642-655

Responsible Party: Metaxia Bareka, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01194505     History of Changes
Other Study ID Numbers: ACLObturator
Study First Received: September 1, 2010
Last Updated: December 4, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Larissa University Hospital:
anterior cruciate ligament reconstruction
obturator nerve block
sciatic nerve block
femoral nerve block
posterior lumbar plexus block
ultrasound guided nerve block

ClinicalTrials.gov processed this record on April 17, 2014