Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

• Conditions: Epidural Analgesia After Major Open Abdominal Surgery
• Interventions: Other: postoperative pain assess

• Registration Number: NCT04912557
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Study Start: 2021-06-14
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	postoperative pain assess	Open major abdominal surgery patient (predicted operative time ≥ 2 hours) with Peridural Analgesia accepted

Primary Outcome Measures

Name	Time	Method
Insufficient epidural analgesia	day 5	Insufficient epidural analgesia will be defined by the presence of pain assessed by numerical scale \> 3/10 at rest OR on coughing OR on mobilization.

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France