AzTrials
AzTrials

Anterior Cruciate LigamentNCT01194505

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

A study testing Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block in people with Anterior Cruciate Ligament and Surgery, run by Larissa University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Anterior Cruciate Ligament, Surgery
What is being tested?
Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteGreece
Study dates
Jun 2010to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Larissa University Hospital

    Larissa, Thessaly, 41110

Other trials in Greece

About this study

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

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.

Being tested
Sciatic, femoral, obturator nerve blocks, Sciatic nerve block, posterior lumbar plexus block
Keywords
anterior cruciate ligament reconstruction, obturator nerve block, sciatic nerve block, femoral nerve block, posterior lumbar plexus block, ultrasound guided nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sciatic, femoral, obturator nerve blocksOther

    Ultrasound guided blocks with ropivacaine

  • Sciatic nerve block, posterior lumbar plexus blockOther

    Ultrasound and neurostimulator nerve blocks with ropivacaine

Study groups in NCT01194505
Study groupRoleWhat they receive
ACL, sciatic, femoral, obturatorActive comparatorACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Receives: Other: Sciatic, femoral, obturator nerve blocks
ACL, sciatic nerve block, posterior lumbar plexus blockActive comparatorACL reconstruction surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block
Receives: Other: Sciatic nerve block, posterior lumbar plexus block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 45 min

Secondary outcomes (2)

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

    Measured: Intraoperatively

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

    Measured: 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionApr 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194505
Sponsor's protocol ID
ACLObturator
Status last verified
Sep 2019
First submitted
1 Sep 2010
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
No

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. doi: 10.1007/s00101-009-1649-2. No abstract available. German.

    PubMed 20094695

  • 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.

    PubMed 15690265

  • 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.

    PubMed 9527749

  • 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.

    PubMed 15781509

  • 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.

    PubMed 14500148

  • 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.

    PubMed 15968551

  • 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.

    PubMed 19672183

  • 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.

    PubMed 4796576

  • 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.

    PubMed 17576526

  • 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.

    PubMed 19843807

  • 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.

    PubMed 16301239

  • 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.

    PubMed 10021959

  • 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.

    PubMed 6051731

  • 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.

    PubMed 24363843

Questions about this trial

What is this clinical trial studying?

A study testing Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block in people with Anterior Cruciate Ligament and Surgery, run by Larissa University Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01194505, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in