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

NCT03693755 | Completed

• 1 other identifier: 2018-00940
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

• Dislocation of the femoral nerve catheter at 48 hours after its placement.

  The catheter will be checked if in the right place using ultrasound location

  48 hours after the placement of the catheter

Secondary Outcomes (7)

• Time to place the catheter

  30min (time needed to place and fix a femoral catheter)

• satisfaction of the patient

  48 hours after the placement of the catheter

• number of failed blocks

  30min (time needed to place and fix a femoral catheter and regognize if it works)

• difficulty placing the catheter

  30min (time needed to place and fix a femoral catheter and to decide if it was difficult)

• Effect of the femoral catheter on the sensory sensation

  at 24 hours and 48 hours after the femoral nerve catheter

Study Arms (2)

In-plane Group

ACTIVE COMPARATOR

In this Group the femoral nerve catheter will be placed with the in-plane technique.

Procedure: In-plane Group; Procedure: Out-of-plane Group

Out-of-plane Group

ACTIVE COMPARATOR

In this Group the femoral nerve catheter will be placed with the out-of-plane technique.

Procedure: In-plane Group; Procedure: Out-of-plane Group

Interventions

In-plane Group PROCEDURE

Placement of femoral nerve catheter under ultrasound control

In-plane Group; Out-of-plane Group

Out-of-plane Group PROCEDURE

Placement of femoral nerve catheter under ultrasound control

In-plane Group; Out-of-plane Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Aguirre: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

• Kalimeris K, Rupnik B, Allenspach K, Fucentese SF, Gotschi T, Aguirre J, Eichenberger U. Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):758-764. doi: 10.1097/EJA.0000000000001237.

  PMID: 32453168 DERIVED

Study Officials

• Urs Eichenberger, Prof. Dr. med.

  Department of Anaesthesia, Intensive Care and Pain Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The Patient will not be told in which Group he belongs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med José A. Aguirre, MSc, Senior Consultant Anesthetist

Model Details: 1 Group will be compared to another

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: October 3, 2018
• Study Start: October 24, 2018
• Primary Completion: February 20, 2019
• Study Completion: May 28, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)