Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study (PERIDIGE)

August 13, 2014 updated by: University Hospital, Limoges

Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.

Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

There are currently two methods of analgesia in postoperative abdominal surgery : patient-controlled analgesia (PCA) with opioids and epidural analgesia.

No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU de Limoges - Service d'anesthésie-réanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgery scheduled under laparotomy
  • Extended ileal resection
  • Total proctocolectomy
  • Colectomy left/right/total
  • Rectosigmoidal resection
  • Anterior resection of rectum
  • Abdomino-perineal amputation
  • Adult patient
  • Written consent obtained
  • Planned hospitalization in the intensive care unit
  • Patient affiliated to social security

Exclusion Criteria:

  • Patients inapt to give consent
  • Emergency surgery
  • Contraindication to epidural analgesia
  • Contraindication to levobupivacaïne, morphine or sufentanil
  • Dementia
  • Participation in another research protocol
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APD
patient with epidural analgesia
Procedure: epidural analgesia
thoracic position (T8-T9 or T11-T12) depending on the site of surgery
Active Comparator: PCA
Patient with morphine analgesia
Procedure: PCA
Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theoretical duration of hospitalization in intensive care unit.
Time Frame: 5 days
The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of hospitalization.
Time Frame: 9 days
The difference between the day of surgery and the day when the discharge criteria are met
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Nathalie NATHAN-DENIZOT, MD, Limoges UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I10030 PERIDIGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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