Peripheral Nerve Block (Femoral - Sciatic - Obturator) Ve... | NCT02186899

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

NCT02186899

Sponsor

Larissa University Hospital

Status

Unknown status

Last Update Posted

Jul 10, 2014Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Arthroscopic ACL Rerpair
Surgery
Anesthesia Care

Interventions

Ultrasound Guided Femoral Sciatic Obturator nerve blocks
General Anesthesia femoral bolus
General anesthesia femoral continuous

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Apr 27, 2014

First Submission Date that Met QC Criteria

Jul 7, 2014

First Posted Date

Jul 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2014

Last Update Posted Date

Jul 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marina Simaioforidou, Anesthesiologist, Larissa University HospitalPrincipal Investigator

Lead Sponsor

Larissa University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General Anesthesia Femoral continuous	Active Comparator	General anesthesia plus continuous femoral nerve block	Other: General anesthesia femoral continuous
General anesthesia Femoral bolus	Active Comparator	General anesthesia plus single shot femoral nerve block	Other: General Anesthesia femoral bolus
Femoral Sciatic Obturator Nerve block	Active Comparator	Ultrasound guided femoral plus sciatic plus obturator nerve block	Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Guided Femoral Sciatic Obturator nerve blocks	Other		Femoral Sciatic Obturator Nerve block
General Anesthesia femoral bolus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marina Simaioforidou, Medicine	Contact	00306947845083		msimaiof@otenet.gr

Overall Officials

Name	Affiliation	Role
Marina Simaioforidou, Medicine	Private Clinic of Larissa "Asklipeiio"	Study Director
George Basdekis, Medicine	Private Clinic of Larissa "Asklipeiio"	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Private Clinic of Larissa "Asklipeiio"	Recruiting	Larissa	Larissa		Greece

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.