Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470846

Acronym

PERIDIGE

Enrollment

Registered

2011-11-11

Start date

2011-11-30

Completion date

2013-04-30

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

epidural analgesia, morphin analgesia, laparotomy

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.

Interventions

PROCEDUREepidural analgesia

thoracic position (T8-T9 or T11-T12) depending on the site of surgery

PROCEDUREPCA

Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026