Clinical trial NCT04912557: Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery
Official title: Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural Analgesia After Major Open Abdominal Surgery
Keywords: epidural analgesia
open abdominal surgery
postoperative pain
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with major abdominal surgery operated by laparotomy

Brief summary: Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Detailed description: Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.

In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.

Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
* epidural analgesia accepted

Exclusion Criteria:

* Minor or protected patient
* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breastfeeding woman
* Contraindication or refusal of epidural analgesia
* Failure of the initial placement of the epidural catheter
* Major intraoperative complication requiring continued postoperative sedation

Primary outcomes:
measure: Insufficient epidural analgesia
timeFrame: day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Guillaume PORTA-BONETE, MD
role: PRINCIPAL_INVESTIGATOR
References: