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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Jun 2024 → ongoing

Decision date (initial)

2024-03-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU Amiens-Picardie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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 objectives 4

1. The intensity of acute postoperative pain at 24 and 48 hours postoperatively
2. The time limit for resorting to level III analgesics within 24 hours post-operatively
3. Consumption of opioid derivatives and opioids at 24 h, 48 h and 3 months after surgery
4. The intensity of pain at 3 months and the incidence of neuropathic pain at 3 months after surgery

Conditions and MedDRA coding

Chronic postsurgical pain in non-major scheduled abdominal surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age > 18 years old
2. Non-major scheduled abdominal surgery.
3. Written or oral informed consent to participate in the study.

Exclusion criteria 8

1. Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued
2. Repeat surgery at the same surgical site in less than 3 months
3. Ambulatory surgery and Endoscopic surgery
4. Surgery with loco-regional or perimedullary anesthesia without general anesthesia
5. Intraoperative use of an opioid other than Sufentanil
6. Patients suffering from psychiatric pathologies
7. Patients suffering from neurodegenerative pathologies
8. Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc…)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

1. Post-operative pain intensity assessed by NRS of 11 points at 24 hours and 48 hours after operating room discharge
2. Time taken until the use of 3rd step analgesics
3. Consumption of opioid derivatives and opioids at 24 hours, 48 hours and 3 months after surgery
4. CPSP intensity at 3 months and neuropathic pain incidence at 3 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Médecin

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Médecin

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications