Clinical trial • Not applicable • Gastroenterology
SUFENTANIL for Chronic postsurgical pain | Chronic postsurgical pain after non-major scheduled abdominal surgery
Not applicable trial of SUFENTANIL for Chronic postsurgical pain | Chronic postsurgical pain after non-major scheduled abdominal surgery. 855 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Chronic postsurgical pain | Chronic postsurgical pain after non-major scheduled abdominal surgery
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-12-2023
- First CTIS Authorization Date
- 22-03-2024
Trial design
Not applicable trial across 1 site in France.
- Target Sample Size
- 855
- Trial Duration For Participant
- 90
Eligibility
Recruits 855 Vulnerable population not selected. Study includes adults only (>18 years). Written or oral informed consent required; no specific assent process or additional consent procedures for vulnerable groups are specified..
- Vulnerable Population
- Vulnerable population not selected. Study includes adults only (>18 years). Written or oral informed consent required; no specific assent process or additional consent procedures for vulnerable groups are specified.
Inclusion criteria
- {"criterion_text":"- Age > 18 years old\n- Non-major scheduled abdominal surgery.\n- Written or oral informed consent to participate in the study."}
Exclusion criteria
- {"criterion_text":"- Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued\n- Repeat surgery at the same surgical site in less than 3 months\n- Ambulatory surgery and Endoscopic surgery\n- Surgery with loco-regional or perimedullary anesthesia without general anesthesia\n- Intraoperative use of an opioid other than Sufentanil\n- Patients suffering from psychiatric pathologies\n- Patients suffering from neurodegenerative pathologies\n- Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc…)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of CPSP at 3 months after non-major scheduled abdominal surgery","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Post-operative pain intensity assessed by NRS of 11 points at 24 hours and 48 hours after operating room discharge","definition_or_measurement_approach":"Measured using an 11-point Numerical Rating Scale (NRS) at 24 and 48 hours after operating room discharge."}
- {"endpoint_text":"- Time taken until the use of 3rd step analgesics","definition_or_measurement_approach":"Time to first use of WHO step-III analgesics (measurement approach not further specified)."}
- {"endpoint_text":"- Consumption of opioid derivatives and opioids at 24 hours, 48 hours and 3 months after surgery","definition_or_measurement_approach":"Opioid consumption measured at 24 h, 48 h and 3 months after surgery (units/method not further specified)."}
- {"endpoint_text":"- CPSP intensity at 3 months and neuropathic pain incidence at 3 months.","definition_or_measurement_approach":"Assessment of CPSP intensity and incidence of neuropathic pain at 3 months (specific scales/methods not specified)."}
Recruitment
- Planned Sample Size
- 855
- Recruitment Window Months
- 27
- Consent Approach
- Written or oral informed consent to participate in the study is required. Study population restricted to adults (>18 years). No additional details on assent, age-specific documents, or languages provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 855
France
- Earliest CTIS Part Ii Submission Date
- 21-02-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 855
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- RPIN TARPIN
- Principal Investigator Email
- Tarpin.Paul@chu-amiens.fr
- Contact Person Name
- RPIN TARPIN
- Contact Person Email
- Tarpin.Paul@chu-amiens.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- SUFENTANIL
- Active Substance
- SUFENTANIL
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 30 µg/Kg per day; max total 120 µg/Kg
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