NCT01194505

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

September 1, 2010

Last Update Submit

September 24, 2019

Conditions

Anterior Cruciate LigamentSurgery

Keywords

anterior cruciate ligament reconstructionobturator nerve blocksciatic nerve blockfemoral nerve blockposterior lumbar plexus blockultrasound guided nerve block

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (2)

  • Intraoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

    Intraoperatively

  • Postoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

    24h

Study Arms (2)

ACL, sciatic, femoral, obturator

ACTIVE COMPARATOR

ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

Other: Sciatic, femoral, obturator nerve blocks

ACL, sciatic nerve block, posterior lumbar plexus block

ACTIVE COMPARATOR

ACL reconstruction surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block

Other: Sciatic nerve block, posterior lumbar plexus block

Interventions

Sciatic, femoral, obturator nerve blocksOTHER

Ultrasound guided blocks with ropivacaine

ACL, sciatic, femoral, obturator
Sciatic nerve block, posterior lumbar plexus blockOTHER

Ultrasound and neurostimulator nerve blocks with ropivacaine

ACL, sciatic nerve block, posterior lumbar plexus block

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larissa University Hospital

Larissa, Thessaly, 41110, Greece

Location

Related Publications (16)

  • 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.

    PMID: 20094695BACKGROUND

  • 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.

    PMID: 15690265BACKGROUND

  • 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.

    PMID: 9527749BACKGROUND

  • 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.

    PMID: 15781509BACKGROUND

  • 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.

    PMID: 14500148BACKGROUND

  • 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.

    PMID: 15968551BACKGROUND

  • 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.

    PMID: 19672183BACKGROUND

  • 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.

    PMID: 4796576BACKGROUND

  • 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.

    PMID: 17576526BACKGROUND

  • 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.

    PMID: 19843807BACKGROUND

  • 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.

    PMID: 16301239BACKGROUND

  • 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.

    PMID: 10021959BACKGROUND

  • 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.

    PMID: 6051731BACKGROUND

  • Boezaart A. Continuous femoral Nerve Block for Pain Management in Total Knee Arthoplasty. AAOS, Orthopaedic Knowledge On Line

    BACKGROUND

  • 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.

    PMID: 24363843BACKGROUND

  • 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.

    PMID: 28315922BACKGROUND

Study Officials

  • Metaxia Bareka, Medicine

    Larissa University Hospital

    PRINCIPAL INVESTIGATOR

  • George Vretzakis, Medicine

    Larissa University Hospital

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patient, the orphopaedic surgeon and the anesthesiologist in the OR did not know at which group the patient belonged to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 3, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

GR(1)