Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study (PERIDIGE)
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|ClinicalTrials.gov Identifier: NCT01470846|
Recruitment Status : Terminated (Lack of patients eligible for the study)
First Posted : November 11, 2011
Last Update Posted : August 15, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470846
|CHU de Limoges - Service d'anesthésie-réanimation|
|Limoges, France, 87042|
|Principal Investigator:||Nathalie NATHAN-DENIZOT, MD||Limoges UH|