Comparison of Two Techniques for Placement of Perineural Femoral Catheters.

Postoperative Pain Clinical Trial

— HLOCSTIM2  

Official title:

Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726192
• Other study ID #: HLOCSTIM2
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2012
• Last updated: November 13, 2012
• Start date: August 2012

Study information

• Verified date: November 2012
• Source: Attikon Hospital
• Contact: Tatiana F Sidiropoulou, MD, PhD
• Phone: 00302105832371
• Email: tatianasid[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.

Description:

The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.

Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults

• BMI less than 30

Exclusion Criteria:

• known allergies to local anesthetics or other drugs used

• patient refusal

• any local or systemic contraindication to the use of popliteal block

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Placement of a femoral catheter with the hydrolocalization technique
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
• Placement of a femoral neurostimulating catheter

Locations

Country	Name	City	State
Greece	Attikon Hospital	Athens
Italy	Policlinico Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Countries where clinical trial is conducted

Greece,  Italy, 

References & Publications (1)

Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of side effects, consumption of iv analgesics		36 hours postoperatively	No
Primary	local anesthetic consumption		36 hours postoperatively	No
Secondary	Pain scores with a VAS scale		36 hours postoperatively	No