Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL) - Full Text View

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:

MedlinePlus related topics: Knee Injuries and Disorders Plastic and Cosmetic Surgery

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2013
Estimated 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

Contacts

Contact: Metaxia Bareka, Medicine	00306947845083 ext 1370	barekametaxia@hotmail.com
Contact: George Vretzakis, Medicine	00302413502952 ext 2952	gvretzakis@yahoo.com

Locations

Greece
Larissa University Hospital	Recruiting
Larissa, Thessaly, Greece, 41110
Contact: Metaxia Bareka, Medicine 00306947845083 ext 1370 barekametaxia@hotmail.com
Contact: Eleni Chantzi, Medicine 00306947729732 ext 1370 helenchantzi@gmail.com

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:

Zwissler B. [An exceptional author and publisher is leaving : Retirement of Reinhard Larsen from the editorial board of Der Anaesthesist] Anaesthesist. 2010 Jan;59(1):5-6. German. No abstract available.

Enneking FK, Chan V, Greger J, Hadzi? A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. Review. No abstract available.

Fanelli G, Casati A, Aldegheri G, Beccaria P, Berti M, Leoni A, Torri G. Cardiovascular effects of two different regional anaesthetic techniques for unilateral leg surgery. Acta Anaesthesiol Scand. 1998 Jan;42(1):80-4.

Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-81.

Jankowski CJ, Hebl JR, Stuart MJ, Rock MG, Pagnano MW, Beighley CM, Schroeder DR, Horlocker TT. A comparison of psoas compartment block and spinal and general anesthesia for outpatient knee arthroscopy. Anesth Analg. 2003 Oct;97(4):1003-9, table of contents.

Morin AM, Pandurovic M, Eberhart LH, Wagner S, Kunz C, Nüssle W, Geiger P, Mehrkens HH. [Is a blockade of the lateral cutaneous nerve of the thigh an alternative to the classical femoral nerve blockade for knee joint arthroscopy? A randomised controlled study] Anaesthesist. 2005 Oct;54(10):991-9. German.

Axel R Heller. Precision of Traditional Approaches for Lumbar Plexus Block. Anesthesiology 2009;111:525-32

Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.

Keßler J, Marhofer P, Rapp H, Hollmann MW. Ultraschallgezielte Anaesthesie peripheren Nerven. Anaesthesist 2007;56:642-655

Danelli G, Ghisi D, Fanelli A, Ortu A, Moschini E, Berti M, Ziegler S, Fanelli G. The effects of ultrasound guidance and neurostimulation on the minimum effective anesthetic volume of mepivacaine 1.5% required to block the sciatic nerve using the subgluteal approach. Anesth Analg. 2009 Nov;109(5):1674-8.

Klein SM, Evans H, Nielsen KC, Tucker MS, Warner DS, Steele SM. Peripheral nerve block techniques for ambulatory surgery. Anesth Analg. 2005 Dec;101(6):1663-76. Review.

Greengrass RA, Klein SM, D'Ercole FJ, Gleason DG, Shimer CL, Steele SM. Lumbar plexus and sciatic nerve block for knee arthroplasty: comparison of ropivacaine and bupivacaine. Can J Anaesth. 1998 Nov;45(11):1094-6.

Freeman MA, Wyke B. The innervation of the knee joint. An anatomical and histological study in the cat. J Anat. 1967 Jun;101(Pt 3):505-32. No abstract available.

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, 2012
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 May 19, 2013