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

University of Limoges (UL)

Status and phase: Terminated; Phase 4

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

Treatments: Procedure: PCA; Procedure: epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01470846

I10030 PERIDIGE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

APD

Experimental group

Description:

patient with epidural analgesia

Treatment:

Procedure: epidural analgesia

PCA

Active Comparator group

Description:

Patient with morphine analgesia

Treatment:

Procedure: PCA