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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
Results First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE July 26, 2007
First Posted Date  ICMJE July 27, 2007
Results First Submitted Date  ICMJE October 23, 2018
Results First Posted Date  ICMJE February 25, 2019
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
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 ]
Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00508300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery
Official Title  ICMJE Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Colectomy
Intervention  ICMJE
  • Procedure: Epidural analgesia
    Thoracic epidural analgesia until day 2
  • Procedure: Patient controlled analgesia
    Patient controlled analgesia (morphine-based)
Study Arms  ICMJE
  • A
    Epidural Analgesia (Th 8-9)
    Intervention: Procedure: Epidural analgesia
  • B
    Patient controlled analgesia (morphine-based)
    Intervention: Procedure: Patient controlled analgesia
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2007)
128
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00508300
Other Study ID Numbers  ICMJE P166/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicolas DEMARTINES, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
PRS Account University of Lausanne Hospitals
Verification Date October 2018

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