Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study (PERIDIGE)
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.
|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||Procedure: epidural analgesia Procedure: PCA||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study|
- Theoretical duration of hospitalization in intensive care unit. [ Time Frame: 5 days ]The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.
- Total duration of hospitalization. [ Time Frame: 9 days ]The difference between the day of surgery and the day when the discharge criteria are met
|Study Start Date:||November 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
patient with epidural analgesia
Procedure: epidural analgesia
thoracic position (T8-T9 or T11-T12) depending on the site of surgery
Active Comparator: PCA
Patient with morphine analgesia
Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470846
|CHU de Limoges - Service d'anesthésie-réanimation|
|Limoges, France, 87042|
|Principal Investigator:||Nathalie NATHAN-DENIZOT, MD||Limoges UH|