Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery (EVA)
This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00508300
First received: July 26, 2007
Last updated: April 21, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.
| Condition | Intervention |
|---|---|
|
Laparoscopic Colectomy |
Procedure: Epidural analgesia Procedure: Patient controlled analgesia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial |
Further study details as provided by University of Lausanne Hospitals:
Primary Outcome Measures:
- medical recovery (defined as pain sufficient controlled by oral analgesia, fully mobile patients or at least as mobile as at admission and tolerance of the patient of oral food intake (more than 2/3 of daily meal)) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- complication rate, peridural analgesia failure rate, patient comfort [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 128 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A
Epidural Analgesia (Th 8-9)
|
Procedure: Epidural analgesia
Thoracic epidural analgesia until day 2
|
|
B
Patient controlled analgesia (morphine-based)
|
Procedure: Patient controlled analgesia
Patient controlled analgesia (morphine-based)
|
Detailed Description:
Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.
Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients admitted for elective laparoscopic colonic surgery
Exclusion Criteria:
- Age < 18y
- No informed consent
- Emergency situation
- Contraindication for EDA (according to local Anesthesia guidelines)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508300
Contacts
| Contact: Martin Hubner, MD | +41 21 314 2418 | martin.hubner@chuv.ch |
| Contact: Nicolas Demartines, MD | +41 21 314 2400 | demartines@chuv.ch |
Locations
| Switzerland | |
| Department of Visceral Surgery, University Hospital CHUV, Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Martin Hübner, MD +41 21 314 2418 martin.hubner@chuv.ch | |
| Contact: Nicolas Demartines, MD +41 21 314 2400 demartines@chuv.ch | |
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
| Study Chair: | Nicolas Demartines, MD | Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland |
More Information
No publications provided
| Responsible Party: | Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT00508300 History of Changes |
| Other Study ID Numbers: | P166/07 |
| Study First Received: | July 26, 2007 |
| Last Updated: | April 21, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Lausanne Hospitals:
|
laparoscopic colectomy Fast Track epidural |
ClinicalTrials.gov processed this record on May 16, 2013