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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:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01470846
First received: November 8, 2011
Last updated: April 16, 2013
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Theoretical duration of hospitalization in intensive care unit. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The difference between the day of surgery and the day when the discharge criteria are met


Enrollment: 35
Study Start Date: November 2011
Estimated Study Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01470846     History of Changes
Other Study ID Numbers: I10030 PERIDIGE
Study First Received: November 8, 2011
Last Updated: April 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 22, 2013