Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Colectomy
- Sponsor
- University of Lausanne Hospitals
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- 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))
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nicolas DEMARTINES
professor of surgery
University of Lausanne Hospitals
Eligibility 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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort(30 days)