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

NCT00508300 | Completed Results

• 1 other identifier: P166/07
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Colectomy

Keywords

laparoscopic; colectomy; Fast Track; epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort

  30 days

Study Arms (2)

A

OTHER

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.

Procedure: Epidural analgesia

B

OTHER

Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed.

Procedure: Patient controlled analgesia

Interventions

Epidural analgesia PROCEDURE

Thoracic epidural analgesia until day 2

A

Patient controlled analgesia PROCEDURE

Patient controlled analgesia (morphine-based)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted for elective laparoscopic colonic surgery

You may not qualify if:

• Age \< 18y
• No informed consent
• Emergency situation
• Contraindication for EDA (according to local Anesthesia guidelines)

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Department of Visceral Surgery, University Hospital CHUV, Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• Hubner 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.

  PMID: 25119117 DERIVED

MeSH Terms

Interventions

Analgesia, Epidural; Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: martin hübner
• Organization: lausanne university hospital

martin.hubner@chuv.ch

+41795561506

Study Officials

• Nicolas Demartines, MD

  Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of surgery

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: January 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 11, 2020
• Results First Posted: February 25, 2019

Record last verified: 2020-07

Locations

CH (1)