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Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery (EVA)

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ClinicalTrials.gov Identifier: NCT00508300
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Brief Summary:
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 or disease Intervention/treatment
Laparoscopic Colectomy Procedure: Epidural analgesia Procedure: Patient controlled analgesia

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2010
Primary Completion Date : October 2013
Study Completion Date : October 2013

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. complication rate, peridural analgesia failure rate, patient comfort [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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): NCT00508300


Locations
Switzerland
Department of Visceral Surgery, University Hospital CHUV, Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00508300     History of Changes
Other Study ID Numbers: P166/07
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
laparoscopic
colectomy
Fast Track
epidural