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NCT Number: NCT06374849

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

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.

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Key information

Conditions

Chronic Postsurgical Pain Abdominal Surgery Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Risk Factors Signs and Symptoms Sufentanil

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of CPSP

    Time frame: at 3 months

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

Secondary outcomes

  1. Post-operative pain intensity

    Time frame: at 24 hours

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

  2. Post-operative pain intensity

    Time frame: at 48 hours

    Post-operative pain intensity assessed by NRS of 11 points at 48 hours after operating room discharge

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ISPAIN

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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