Intraoperative Sufentanil and chronic postsurgical pain in non-major scheduled abdominal surgery

Phase 1

Conditions: Chronic postsurgical pain in non-major scheduled abdominal surgery
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2023-510140-21-00

Lead Sponsor: Centre Hospitalier Universitaire Amiens Picardie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 855

Inclusion Criteria

Age > 18 years old, Non-major scheduled abdominal surgery., 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, Ambulatory surgery and Endoscopic surgery, Surgery with loco-regional or perimedullary anesthesia without general anesthesia, Intraoperative use of an opioid other than Sufentanil, 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: The intensity of acute postoperative pain at 24 and 48 hours postoperatively, The time limit for resorting to level III analgesics within 24 hours post-operatively, Consumption of opioid derivatives and opioids at 24 h, 48 h and 3 months after surgery, The intensity of pain at 3 months and the incidence of neuropathic pain at 3 months after surgery;Primary end point(s): Incidence of CPSP at 3 months after non-major scheduled abdominal surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Post-operative pain intensity assessed by NRS of 11 points at 24 hours and 48 hours after operating room discharge;Secondary end point(s):Time taken until the use of 3rd step analgesics;Secondary end point(s):Consumption of opioid derivatives and opioids at 24 hours, 48 hours and 3 months after surgery;Secondary end point(s):CPSP intensity at 3 months and neuropathic pain incidence at 3 months.