Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery (PAPCAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Epidural Analgesia After Major Open Abdominal Surgery
• Intervention / Treatment: Other: postoperative pain assess

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Guillaume PORTA-BONETE, MD; Phone Number: +33 5 61 32 35 65; Email: porta-bonete.g@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • University Hospital of Toulouse
    • Contact: Guillaume Porta Bonete, ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients with major abdominal surgery operated by laparotomy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Open major abdominal surgery patient (predicted operative time ≥ 2 hours) with Peridural Analgesia accepted	Other: postoperative pain assess; numerical pain scale and Metameric levels of cold insensitivity; Other Names: numerical pain scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insufficient epidural analgesia	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.	day 5

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Guillaume PORTA-BONETE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: epidural analgesia; postoperative pain; open abdominal surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: RC31/21/0160; 2021-A00926-35 (Other Identifier: IC RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No