Insertion Distance of Thoracic Epidural Catheters in the Context of Thoracotomy Procedures.

This study is currently recruiting participants.

Verified by Centre hospitalier de l'Université de Montréal (CHUM), June 2009

First Received: September 15, 2008 Last Updated: June 3, 2009 History of Changes

Sponsored by:	Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT00754195

Purpose

This study is designed to compare thoracic epidural catheter insertion distances, in order to determine which is the best for pain relief following a thoracotomy.

HYPOTHESIS :

The quality of the sensory blockade will not be inferior if the catheter is inserted deeper (7 cm compared to 3 and 5 cm)
The quality of the sensory blockade at 72-96 h will not be inferior if the catheter is inserted at 3 cm.

Condition	Intervention
Pain	Other: Thoracic epidural catheter

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of the Insertion Distance on Loss of Sensation Produced by Thoracic Epidural Catheters in the Context of Thoracotomy Procedures.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:

Quality of sensory block [ Time Frame: 72-96 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of pain relief [ Time Frame: 72-96 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Insertion distance of thoracic epidural catheter: 3 cm	Other: Thoracic epidural catheter Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
2: Active Comparator Insertion distance of thoracic epidural catheter: 5 cm	Other: Thoracic epidural catheter Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
3: Active Comparator Insertion distance of thoracic epidural catheter: 7 cm	Other: Thoracic epidural catheter Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18 years and older undergoing an elective thoracotomy.

Exclusion Criteria:

Infection or sepsis
Coagulopathy
Hypovolemia
Allergy to local anesthetics
Neuropathy that could affect study assessments
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754195

Contacts

Contact: Stephan R Williams, MD, PhD	514-890-8000 ext 26124	stephan.williams@umontreal.ca
Contact: Monique M Ruel, RN, CCRP	514-890-8000 ext 24542	monique.m.ruel.chum@ssss.gouv.qc.ca

Locations

Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Stephan R Williams, MD, PhD 514-890-8000 ext 26124 stephan.williams@umontreal.ca
Contact: Monique M Ruel, RN, CCRP 514-890-8000 ext 24542 monique.m.ruel.chum@ssss.gouv.qc.ca

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator:

Stephan R Williams, MD, PhD

Centre Hospitalier de l'Université de Montréal

More Information

No publications provided

Responsible Party:	Centre Hospitalier de l'Université de Montréal ( Dr Stephan R Williams )
Study ID Numbers:	08.071
Study First Received:	September 15, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00754195 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):

Thoracotomy

Study placed in the following topic categories:

Hypesthesia
Pain

ClinicalTrials.gov processed this record on September 11, 2009