NCT01597466CompletedNot Applicable
A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Ease to identify the epidural space
Study Overview
Brief Summary
The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective major thoracic surgery requiring thoracic epidural analgesia
Exclusion Criteria
- •Contraindication to epidural anesthesia
- •Marked spinal deformities or a history of spinal instrumentation
Arms & Interventions
Epidrum
Experimental
Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
Intervention: Epidural catheter placement (Device)
Loss of resistance technique
Active Comparator
Intervention: Epidural catheter placement (Procedure)
Outcomes
Primary Outcomes
Ease to identify the epidural space
Time Frame: 30 minutes
Number of cases having required more than 2 punctures and number of failures of the technique
Secondary Outcomes
- Number of cutaneous punctures(30 minutes)
- Ease of epidural catheter insertion(30 minutes)
- Number of inadequate postoperative analgesia(one day after anesthesia)
- Duration of epidural procedure(30 minutes)
- Number of needle redirections(30 minutes)
Investigators
Study Sites (2)
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