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TerminatedNCT01470846PERIDIGEUpdated Aug 15, 2014

Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

A Phase 4 interventional study of epidural analgesia and PCA in Extended Ileal Resection Under Laparotomy, Total Proctocolectomy Under Laparotomy and Colectomy Left/Right/Total Under Laparotomy, sponsored by University Hospital, Limoges. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-15.

Sponsored by University Hospital, Limoges · Phase 4, Interventional, and Treatment

Why this study was terminated
Lack of patients eligible for the study
Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Extended Ileal Resection Under Laparotomy
  • Total Proctocolectomy Under Laparotomy
  • Colectomy Left/Right/Total Under Laparotomy
  • Rectosigmoidal Resection Under Laparotomy
  • Anterior Resection of Rectum Under Laparotomy
  • Abdomino-perineal Amputation Under Laparotomy

Keywords

  • epidural analgesia
  • morphin analgesia
  • laparotomy
03

In context

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    APD

    patient with epidural analgesia

    Procedure: epidural analgesia

  • Active comparator
    PCA

    Patient with morphine analgesia

    Procedure: PCA

Interventions

  • Procedureepidural analgesia

    thoracic position (T8-T9 or T11-T12) depending on the site of surgery

  • ProcedurePCA

    Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.

06

What researchers measure

Primary outcomes

  1. Theoretical duration of hospitalization in intensive care unit.

    The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.

    Time frame: 5 days

Secondary outcomes

  1. Total duration of hospitalization.

    The difference between the day of surgery and the day when the discharge criteria are met

    Time frame: 9 days

07

Study locations

1 site
  • CHU de Limoges - Service d'anesthésie-réanimation
    Limoges, 87042, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01470846
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Nov 11, 2011
Start date
Nov 2011
Primary completion
Mar 2013
Completion
Apr 2013
Last update
Aug 15, 2014

Study contacts

Nathalie NATHAN-DENIZOT, MD
principal investigator · Limoges UH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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