Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery (ISPAIN)

Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.

In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Abdominal Surgery; Risk Factors; Chronic Postsurgical Pain; Sufentanil
• Intervention / Treatment: Other: phone interview

• Study Type: Interventional
• Enrollment (Estimated): 855
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens-Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years old.
• Non-major scheduled abdominal surgery.
• Patient will receive Sufentanil intraoperatively for induction and maintenance of general anesthesia
• Written or oral informed consent to participate in the study.

Exclusion Criteria:

• Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
• Repeat surgery at the same surgical site in less than 3 months.
• Pregnancy.
• Ambulatory surgery.
• Endoscopic surgery.
• Surgery with loco-regional or perimedullary anesthesia without general anesthesia
• Intraoperative use of an opioid other than Sufentanil.
• Hypersensitivity to sufentanil
• Legally protected patients (under judicial protection, guardianship, curatorship).
• Patients suffering from psychiatric pathologies.
• Patients suffering from neurodegenerative pathologies.
• Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CPSP	Incidence of CPSP at 3 months after non-major scheduled abdominal surgery	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain intensity	Post-operative pain intensity assessed by NRS of 11 points at 24 hours after operating room discharge	at 24 hours
Post-operative pain intensity	Post-operative pain intensity assessed by NRS of 11 points at 48 hours after operating room discharge	at 48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pain; Risk factors; Sufentanil; Abdominal surgery; Chronic Postsurgical Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: PI2023_843_0173

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
• product manufactured in and exported from the U.S.: No