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

NCT06374849 | Active Not Recruiting Phase 4

• 1 other identifier: PI2023_843_0173
• Study Type: interventional
• Target: 855
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Postsurgical Pain; Chronic Pain; Abdominal Surgery; Sufentanil; Risk Factors

Keywords

Chronic Postsurgical Pain; Chronic pain; Abdominal surgery; Sufentanil; Risk factors

Outcome Measures

Primary Outcomes (1)

• Incidence of CPSP

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

  at 3 months

Secondary Outcomes (2)

• Post-operative pain intensity

  at 24 hours

• Post-operative pain intensity

  at 48 hours

Interventions

phone interview OTHER

Patient's phone interview 3 months after operating room discharge. The interview consisting of 3 questionnaires to detect the presence of CPSP, its intensity, its characteristics and its related analgesic consumption.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: June 24, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)