We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754195
First Posted: September 17, 2008
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
  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 epidural analgesia upon coughing one hour following the end of surgery will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3 and 5 cm.
  2. The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.

Condition Intervention
Pain Other: Thoracic epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia 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 pain relief during cough [ Time Frame: At one hour and 24 hours after surgery ]

Secondary Outcome Measures:
  • Quality of pain relief at rest [ Time Frame: At one hour and 24 hours after surgery ]
  • Proportion of failed epidurals [ Time Frame: At one hour and 24 hours after surgery ]
  • Wound palpation pain [ Time Frame: At one hour and 24 hours after surgery ]
  • Loss of cold sensation around the wound [ Time Frame: At one hour and 24 hours after surgery ]
  • Cumulative bupivacaine and morphine consumption [ Time Frame: At one hour and 24 hours after surgery ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 (CHUM)
  More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00754195     History of Changes
Other Study ID Numbers: 08.071
First Submitted: September 15, 2008
First Posted: September 17, 2008
Last Update Posted: February 23, 2015
Last Verified: February 2015

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