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

Laparoscopic Colectomy Clinical Trial

— EVA  

Official title:

Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508300
• Other study ID #: P166/07
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Colectomy

Intervention

Procedure:
• Epidural analgesia
Thoracic epidural analgesia until day 2
• Patient controlled analgesia
Patient controlled analgesia (morphine-based)

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital CHUV, Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	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	30 days
Secondary	Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort		30 days