- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194505
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
- Enneking FK, Chan V, Greger J, Hadzic 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. doi: 10.1016/j.rapm.2004.10.002. No abstract available.
- 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. doi: 10.1007/s00101-009-1649-2. No abstract available. German.
- 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. doi: 10.1111/j.1399-6576.1998.tb05084.x.
- 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):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.
- 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):1003-1009. doi: 10.1213/01.ANE.0000081798.89853.E7.
- Morin AM, Pandurovic M, Eberhart LH, Wagner S, Kunz C, Nussle 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. doi: 10.1007/s00101-005-0879-1. German.
- Heller AR, Fuchs A, Rossel T, Vicent O, Wiessner D, Funk RH, Koch T, Litz RJ. Precision of traditional approaches for lumbar plexus block: impact and management of interindividual anatomic variability. Anesthesiology. 2009 Sep;111(3):525-32. doi: 10.1097/ALN.0b013e3181af64b6.
- 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 HJ, Hollmann MW. [Ultrasound-guided anaesthesia of peripheral nerves. The new challenge for anaesthesiologists]. Anaesthesist. 2007 Jul;56(7):642-55. doi: 10.1007/s00101-007-1223-8. German.
- 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. doi: 10.1213/ANE.0b013e3181b92372.
- 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):1663-1676. doi: 10.1213/01.ANE.0000184187.02887.24.
- 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. doi: 10.1007/BF03012398.
- 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.
- Boezaart A. Continuous femoral Nerve Block for Pain Management in Total Knee Arthoplasty. AAOS, Orthopaedic Knowledge On Line
- Simeoforidou M, Bareka M, Basdekis G, Tsiaka K, Chantzi E, Vretzakis G. Peripheral nerve blockade as an exclusive approach to obturator nerve block in anterior cruciate ligament reconstructive surgery. Korean J Anesthesiol. 2013 Nov;65(5):410-7. doi: 10.4097/kjae.2013.65.5.410. Epub 2013 Nov 29.
- Bareka M, Hantes M, Arnaoutoglou E, Vretzakis G. Superior perioperative analgesia with combined femoral-obturator-sciatic nerve block in comparison with posterior lumbar plexus and sciatic nerve block for ACL reconstructive surgery. Knee Surg Sports Traumatol Arthrosc. 2018 Feb;26(2):478-484. doi: 10.1007/s00167-017-4525-7. Epub 2017 Mar 18.
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
Terms related to this study
Keywords
Other Study ID Numbers
- ACLObturator
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.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
Clinical Trials on Sciatic, femoral, obturator nerve blocks
-
Larissa University HospitalUnknownSurgery | Arthroscopic ACL Rerpair | Anesthesia CareGreece
-
Larissa University HospitalUnknownSurgery | Total Knee ReplacementGreece
-
Clinique Medipole GaronneCompletedPrimary Total Knee ArthroplastyFrance
-
Children's Hospital of PhiladelphiaChildren's Anesthesiology Associates, Ltd.WithdrawnSciatic Nerve AH | Peripheral Nerves US
-
Lithuanian University of Health SciencesCompletedTotal Knee ArthroplastyLithuania
-
Yeungnam University College of MedicineUnknownPostoperative PainKorea, Republic of
-
Centro Hospitalar do PortoUniversidade do PortoCompleted
-
Hillel Yaffe Medical CenterCompletedPost-operative PainIsrael
-
University of California, San DiegoTerminatedFoot SurgeryUnited States
-
Bagcilar Training and Research HospitalCompleted