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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00754195
First received: September 15, 2008
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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 :

  1. The quality of the sensory blockade one hour following the end of surgery will not be inferior if the catheter is inserted deeper (7 cm compared to 3 and 5 cm)
  2. The quality of the sensory blockade at 24 and 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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: At one hour, 24 hours and 72-96 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of pain relief [ Time Frame: At one hour, 24 hours and 72-96 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Active Comparator: 2
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.
Active Comparator: 3
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.

  Show Detailed Description

  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

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, Canada, H2L 4M1
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 (CHUM)
ClinicalTrials.gov Identifier: NCT00754195     History of Changes
Other Study ID Numbers: 08.071
Study First Received: September 15, 2008
Last Updated: April 18, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 16, 2013