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
  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 ]

Enrollment: 128
Study Start Date: January 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: February 21, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on October 21, 2014