Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

Phase 4

Terminated

• Conditions: Extended Ileal Resection Under Laparotomy; Colectomy Left/Right/Total Under Laparotomy; Abdomino-perineal Amputation Under Laparotomy; Total Proctocolectomy Under Laparotomy; Rectosigmoidal Resection Under Laparotomy; Anterior Resection of Rectum Under Laparotomy
• Interventions: Procedure: PCA; Procedure: epidural analgesia

• Registration Number: NCT01470846
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCA	PCA	Patient with morphine analgesia
APD	epidural analgesia	patient with epidural analgesia

Primary Outcome Measures

Name	Time	Method
Theoretical duration of hospitalization in intensive care unit.	5 days	The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.

Secondary Outcome Measures

Name	Time	Method
Total duration of hospitalization.	9 days	The difference between the day of surgery and the day when the discharge criteria are met

Trial Locations

Locations (1)

CHU de Limoges - Service d'anesthésie-réanimation; 🇫🇷 Limoges, France