Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

NCT01470846 | Terminated Phase 4

• 1 other identifier: I10030 PERIDIGE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  5 days

Secondary Outcomes (1)

• Total duration of hospitalization.

  9 days

Study Arms (2)

APD

EXPERIMENTAL

patient with epidural analgesia

Procedure: epidural analgesia

PCA

ACTIVE COMPARATOR

Patient with morphine analgesia

Procedure: PCA

Interventions

epidural analgesia PROCEDURE

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

APD

PCA PROCEDURE

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

PCA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU de Limoges - Service d'anesthésie-réanimation

Limoges, 87042, France

Location

MeSH Terms

Interventions

Analgesia, Epidural; Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Nathalie NATHAN-DENIZOT, MD

  Limoges UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

FR (1)