Clinical trial NCT06374849: Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
Official title: Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Chronic Postsurgical Pain
Chronic Pain
Abdominal Surgery
Sufentanil
Risk Factors
Keywords: Chronic Postsurgical Pain
Chronic pain
Abdominal surgery
Sufentanil
Risk factors
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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...)

Primary outcomes:
measure: Incidence of CPSP
timeFrame: at 3 months
Secondary outcomes:
measure: Post-operative pain intensity
timeFrame: at 24 hours
measure: Post-operative pain intensity
timeFrame: at 48 hours
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References: