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Ultrasound Guided Obturator Nerve Block for Total Knee Replacement (TKR)

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ClinicalTrials.gov Identifier: NCT01755117
Recruitment Status : Unknown
Verified April 2014 by Marina Simaioforidou, Larissa University Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2012
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital

Study Description
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Brief Summary:
Total Knee Replacement 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 or disease Intervention/treatment Phase
Total Knee Replacement Surgery Other: Sciatic, femoral, obturator nerve blocks Other: Sciatic nerve block, posterior lumbar plexus block Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Total Knee Replacement (TKR)
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TKR, sciatic, femoral, obturator
TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
 Other: Sciatic, femoral, obturator nerve blocks
Other Name: Ultrasound guided blocks with ropivacaine
Active Comparator: TKR sciatic nerve block, posterior lumbar plexus block
TKR surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block
 Other: Sciatic nerve block, posterior lumbar plexus block
Other Name: Ultrasound guided blocks with ropivacaine


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of TKR 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: Completion of surgery ]
    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 :
  1. Intraoperative opioid consumption for TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block [ Time Frame: Intaoperatively ]

Other Outcome Measures:
  1. Postoperative opioid consumption [ Time Frame: First 24 postoperative hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 80 yrs
  • ASA I - III
  • TKR 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755117


Contacts
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Contact: Metaxia Bareka, Medicine 00306947845083 ext 1370 barekametaxia@hotmail.com
Contact: Marina Simaioforidou, Medicine 00306947845083 ext 2947 msimaiof@otenet.gr

Locations
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Greece
Larissa University Hospital Recruiting
Larissa, Thessally, Greece, 41110
Contact: Metaxia Bareka, Medicine    00306947845083 ext 1370    barekametaxia@hotmail.com   
Contact: George Vretzakis, Medicine    00302413502952 ext 2952    gvretzakis@yahoo.com   
Sponsors and Collaborators
Larissa University Hospital
Investigators
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Principal Investigator: Marina Simaioforidou, Medicine Larissa University Hospital
Study Chair: Metaxia Bareka, Medicine Larissa University Hospital
Study Chair: George Basdekis, Medicine Larissa University Hospital
Study Chair: Athanasios Drakos, Medicine Larissa University Hospital
Study Chair: Aristeidis Zibis, Medicine Private Clinic of Larissa Asklipeiio
Study Chair: Konstantinos Alexiou, Medicine Larissa University Hospital
More Information
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Publications:

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Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755117    
Other Study ID Numbers: TKR obturator
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents