Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair

July 7, 2014 updated by: Marina Simaioforidou, Larissa University Hospital

Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation

Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

  • Name: Marina Simaioforidou, Medicine
  • Phone Number: 00306947845083
  • Email: msimaiof@otenet.gr

Study Locations

  • Greece
      • Larissa, Greece
        • Recruiting
        • Private Clinic of Larissa "Asklipeiio"
        • Contact:
          • Marina Simaioforidou, Medicine
        • Principal Investigator:
          • Marina Simaioforidou, Medicine

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
  • ACL 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General Anesthesia Femoral continuous
General anesthesia plus continuous femoral nerve block
Other: General anesthesia femoral continuous
Active Comparator: General anesthesia Femoral bolus
General anesthesia plus single shot femoral nerve block
Other: General Anesthesia femoral bolus
Active Comparator: Femoral Sciatic Obturator Nerve block
Ultrasound guided femoral plus sciatic plus obturator nerve block
Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery completed without pain for the patient
Time Frame: Completion of the surgery
Use of VAS score
Completion of the surgery
Postoperative pain
Time Frame: 1st postoperative day
Use of VAS score
1st postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobilization of the knee
Time Frame: 24 weeks postoperatively
How many degrees can the patient bend the knee
24 weeks postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain development
Time Frame: 24 weeks postoperatively
Use of questionnaire for the functional state of the knee and VAS score for the pain
24 weeks postoperatively

Collaborators and Investigators

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

Sponsor

Larissa University Hospital

Investigators

  • Principal Investigator: Metaxia Bareka, Medicine, Larissa University Hospital
  • Study Chair: Athanasios Drakos, Medicine, Larissa University Hospital
  • Study Director: Marina Simaioforidou, Medicine, Private Clinic of Larissa "Asklipeiio"
  • Study Chair: George Basdekis, Medicine, Private Clinic of Larissa "Asklipeiio"
  • Study Chair: Konstantinos Bargiotas, Medicine, Larissa University Hospital
  • Study Chair: Aristeidis Zibis, Medicine, Private Clinic of Larissa "Askipeiio"

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

March 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 27, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSOvsGA

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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