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

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

July 26, 2007
July 27, 2007
February 24, 2014
January 2010
October 2013   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00508300 on Archive Site
complication rate, peridural analgesia failure rate, patient comfort [ Time Frame: 30 days ]
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Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery
Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Laparoscopic Colectomy
  • Procedure: Epidural analgesia
    Thoracic epidural analgesia until day 2
  • Procedure: Patient controlled analgesia
    Patient controlled analgesia (morphine-based)
  • A
    Epidural Analgesia (Th 8-9)
    Intervention: Procedure: Epidural analgesia
  • B
    Patient controlled analgesia (morphine-based)
    Intervention: Procedure: Patient controlled analgesia
Hübner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2013
October 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Nicolas DEMARTINES, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
University of Lausanne Hospitals
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP