Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

NCT ID: NCT01470846

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-04-30

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APD

patient with epidural analgesia

Group Type: EXPERIMENTAL

epidural analgesia

Intervention Type: PROCEDURE

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

PCA

Patient with morphine analgesia

Group Type: ACTIVE_COMPARATOR

PCA

Intervention Type: PROCEDURE

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

Interventions

epidural analgesia

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

Intervention Type: PROCEDURE

PCA

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie NATHAN-DENIZOT, MD

Role: PRINCIPAL_INVESTIGATOR

Limoges UH

Locations

CHU de Limoges - Service d'anesthésie-réanimation

Limoges, , France

Countries

France

Other Identifiers

I10030 PERIDIGE

Identifier Type: -

Identifier Source: org_study_id