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

Chronic Pain Clinical Trial

— ISPAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374849
• Other study ID #: PI2023_843_0173
• Status: Recruiting
• Phase: Phase 4
• Start date: March 17, 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: TARPIN Paul, MD
• Phone: 03.22.08.79.80
• Email: Tarpin.Paul[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 855
• Est. completion date: July 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Abdominal Surgery
• Chronic Pain
• Chronic Postsurgical Pain
• Pain, Postoperative
• Risk Factors
• Sufentanil

Intervention

Other:
• phone interview
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.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CPSP	Incidence of CPSP at 3 months after non-major scheduled abdominal surgery	at 3 months
Secondary	Post-operative pain intensity	Post-operative pain intensity assessed by NRS of 11 points at 24 hours after operating room discharge	at 24 hours
Secondary	Post-operative pain intensity	Post-operative pain intensity assessed by NRS of 11 points at 48 hours after operating room discharge	at 48 hours