Insertion Distance of Thoracic Epidural Catheters in the Context of Thoracotomy Procedures.
Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia in the Context of Thoracotomy Procedures.
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Sep 2008
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 23, 2015
February 1, 2015
1.7 years
September 15, 2008
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of pain relief during cough
At one hour and 24 hours after surgery
Secondary Outcomes (5)
Quality of pain relief at rest
At one hour and 24 hours after surgery
Proportion of failed epidurals
At one hour and 24 hours after surgery
Wound palpation pain
At one hour and 24 hours after surgery
Loss of cold sensation around the wound
At one hour and 24 hours after surgery
Cumulative bupivacaine and morphine consumption
At one hour and 24 hours after surgery
Study Arms (3)
1
ACTIVE COMPARATORInsertion distance of thoracic epidural catheter: 3 cm
2
ACTIVE COMPARATORInsertion distance of thoracic epidural catheter: 5 cm
3
ACTIVE COMPARATORInsertion distance of thoracic epidural catheter: 7 cm
Interventions
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
Eligibility Criteria
You may qualify if:
- Patients aged 18 years and older undergoing an elective thoracotomy.
You may not qualify if:
- Infection or sepsis
- Coagulopathy
- Hypovolemia
- Allergy to local anesthetics
- Neuropathy that could affect study assessments
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, H2L 4M1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan R Williams, MD, PhD
Centre hospitalier de l'Université de Montréal (CHUM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 17, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 23, 2015
Record last verified: 2015-02