Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Konstantinos Kalimeris，Balgrist University Hospital

Tracking Information

First Submitted Date ^ICMJE

June 27, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 7, 2018

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dislocation of the femoral nerve catheter at 48 hours after its placement.[ Time Frame: 48 hours after the placement of the catheter ]

The catheter will be checked if in the right place

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Time to place the catheter[ Time Frame: 30min ]
Time to place the catheter
satisfaction of the patient[ Time Frame: 2 days ]
satisfaction of the Patient during the block procedure in a scale of 0 to 10 (0 being not satisfied at all and 10 being totally satisfied)
number of failed blocks[ Time Frame: 30min ]
number of failed blocks needed to be repeated
difficulty placing the catheter[ Time Frame: 30min ]
difficulty placing the catheter under ultrasound control
sympathetic block[ Time Frame: at 24 hours and 48 hours after the femoral nerve catheter ]
rescue boli given over the catheter in the 48 hours after its placement[ Time Frame: during the 48 hours after the block ]
Dislocation of the femoral nerve catheter at 24 hours after its placement.[ Time Frame: 24 hours after the placement of the catheter ]

Descriptive Information

Brief Title ^ICMJE

Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane

Official Title ^ICMJE

Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane: A Prospective Randomized Study

Brief Summary

Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter will be placed sonographically with the out-of-plane technique

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1 Group will be compared to another
Masking: Interventional
Masking Description:The Patient will not be told in which Group he belongs
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Placement of femoral nerve catheter under ultrasound control
Ultrasound guided femoral nerve catheter

Study Arms

Active Comparator: In-plane Group
In this Group the femoral nerve catheter will be placed with the in-plane technique.
Active Comparator: Out-of-plane Group
In this Group the femoral nerve catheter will be placed with the out-of-plane technique.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2019

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: American Society of Anesthesiologists class I-III patients, both sexes ≥ 18 years old - Patients are undergoing major knie surgery at our University Hospital with standard use of regional anesthesia techniques to provide analgesia Exclusion Criteria: - Contraindications or allergy to the use of local anesthetics or other drugs used in the study. - Women who are pregnant or breast feeding - Women who have the intention to become pregnant during the course of the study - Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator(s) in individual cases - Patients with acute porphyria - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant - Participation in another study with investigational drug within the 30 days preceding and during the present study - Previous enrollment into the current study - BMI > 40 - Local inflammation in the inguinal area - Patient refusal for regional anesthesia or participation in the study - Enrollment of the investigator, his/her family members, employees and other dependent persons

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Konstantinos Kalimeris，Balgrist University Hospital

Study Sponsor ^ICMJE

Balgrist University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Balgrist University Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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