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

This study has been terminated.
(Lack of patients eligible for the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470846
First Posted: November 11, 2011
Last Update Posted: August 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  Purpose

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.


Condition Intervention Phase
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 Procedure: epidural analgesia Procedure: PCA Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Total duration of hospitalization. [ Time Frame: 9 days ]
    The difference between the day of surgery and the day when the discharge criteria are met


Enrollment: 35
Study Start Date: November 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470846


Locations
France
CHU de Limoges - Service d'anesthésie-réanimation
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Nathalie NATHAN-DENIZOT, MD Limoges UH
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01470846     History of Changes
Other Study ID Numbers: I10030 PERIDIGE
First Submitted: November 8, 2011
First Posted: November 11, 2011
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by University Hospital, Limoges:
epidural analgesia
morphin analgesia
laparotomy

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents