Placement of Perineural Catheters in the Popliteal Region

Foot Surgery Clinical Trial

Official title:

Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01546077
• Other study ID #: HLOCSTIM1
• Status: Recruiting
• Phase: Phase 4
• First received: February 3, 2012
• Last updated: November 9, 2012
• Start date: January 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 popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: March 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Surgery

Intervention

Procedure:
• Placement of perineural catheters with Hydrolocalization technique using
Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group

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
Primary	consumption of local anesthetics		36 hours PO	No
Secondary	pain scores		36 hours postoperatively	No