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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Larissa University Hospital
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01755117
First received: December 18, 2012
Last updated: April 27, 2014
Last verified: April 2014
  Purpose

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 Intervention
Total Knee Replacement
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 Total Knee Replacement (TKR)

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • 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 ] [ 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 TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block [ Time Frame: Intaoperatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Postoperative opioid consumption [ Time Frame: First 24 postoperative hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755117

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

Locations
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
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

Publications:
Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755117     History of Changes
Other Study ID Numbers: TKR obturator
Study First Received: December 18, 2012
Last Updated: April 27, 2014
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014