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

Not Applicable

Completed

• Conditions: Laparoscopic Colectomy
• Interventions: Procedure: Epidural analgesia; Procedure: Patient controlled analgesia

• Registration Number: NCT00508300
• Lead Sponsor: University of Lausanne Hospitals

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 Timeline

• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Study Start: 2010-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2018-10-23
• Results First Submitted QC: 2018-10-23
• Results First Posted: 2019-02-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Epidural analgesia	Epidural Analgesia (EDA) An epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.
B	Patient controlled analgesia	Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed.

Primary Outcome Measures

Name	Time	Method
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))	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 Outcome Measures

Name	Time	Method
Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort	30 days

Trial Locations

Locations (1)

Department of Visceral Surgery, University Hospital CHUV, Lausanne; 🇨🇭 Lausanne, Switzerland