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

Phase 4

Active, not recruiting

• Conditions: Abdominal Surgery; Risk Factors; Sufentanil; Chronic Postsurgical Pain; Chronic Pain

• Registration Number: NCT06374849
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-17
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Status Verified: 2025-04
• Primary Completion: 2025-04-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 855

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of CPSP	at 3 months	Incidence of CPSP at 3 months after non-major scheduled abdominal surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative pain intensity	at 48 hours	Post-operative pain intensity assessed by NRS of 11 points at 48 hours after operating room discharge

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France