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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06374849
Acronym
ISPAIN
Enrollment
855
Registered
2024-04-19
Start date
2024-06-24
Completion date
2026-07-31
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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…)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of CPSPat 3 monthsIncidence of CPSP at 3 months after non-major scheduled abdominal surgery

Secondary

MeasureTime frameDescription
Post-operative pain intensityat 24 hoursPost-operative pain intensity assessed by NRS of 11 points at 24 hours after operating room discharge

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026