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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00508300
First received: July 26, 2007
Last updated: February 21, 2014
Last verified: February 2014

July 26, 2007
February 21, 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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00508300 on ClinicalTrials.gov Archive Site
complication rate, peridural analgesia failure rate, patient comfort [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00508300
P166/07
No
Not Provided
Not Provided
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