Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

Conditions
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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

Intervention / Treatment
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* Procedure: epidural analgesia
* Procedure: PCA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APD<br>patient with epidural analgesia | Procedure: epidural analgesia<br>* thoracic position (T8-T9 or T11-T12) depending on the site of surgery<br>|
| Active Comparator: PCA<br>Patient with morphine analgesia | Procedure: PCA<br>* Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of hospitalization. | The difference between the day of surgery and the day when the discharge criteria are met | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, morphin analgesia, laparotomy