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

April 27, 2014 updated by: Marina Simaioforidou, Larissa University Hospital

Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Total Knee Replacement (TKR)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Greece
    • Thessally
      • Larissa, Thessally, Greece, 41110
        • Recruiting
        • Larissa University Hospital
        • Contact:
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ultrasound guided blocks with ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Completion of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative opioid consumption for TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Time Frame: Intaoperatively
Intaoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Postoperative opioid consumption
Time Frame: First 24 postoperative hours
First 24 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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

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

December 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 27, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKR obturator

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.

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