Sufentanil for Acute procedural pain (oocyte retrieval)

Inclusion criteria

• {"criterion_text":"- Female adult undergoing IVF/ART with a planned transvaginal oocyte pick-up at UZ Brussel."}
• {"criterion_text":"- Able to provide informed consent and comply with study procedures (pain ratings during OPU; 24-h follow-up)."}
• {"criterion_text":"- ASA physical status I–III under institutional OPU sedation/analgesia pathways."}
• {"criterion_text":"- Meets institutional safety thresholds for ambulatory OPU (e.g., airway assessment, BMI and comorbidity limits) per site SOPs."}

Exclusion criteria

• {"criterion_text":"- Known allergy or hypersensitivity to Sufentanil, Midazolam, Paracetamol, Diclofenac, Alprazolam, Piritramide, or any excipients of these products."}
• {"criterion_text":"- Inability to understand the study procedures or the local languages (Dutch/French/English) sufficiently to complete the questionnaires."}
• {"criterion_text":"- Current use of MAOIs or within 14 days pre-OPU."}
• {"criterion_text":"- History of substance abuse (opioids/benzodiazepines) within the past year."}
• {"criterion_text":"- Pre-existing chronic pain conditions requiring chronic opioid therapy (Endometriosis is allowed unless the patient is on chronic daily opioids)."}
• {"criterion_text":"- History of substance abuse (alcohol or drugs)."}
• {"criterion_text":"- Severe respiratory disease (e.g., COPD) or sleep apnea."}
• {"criterion_text":"- Uncontrolled psychiatric disorders or severe anxiety preventing cooperation with the procedure."}
• {"criterion_text":"- Natural Cycle / IVM: OPU scheduled for a natural cycle, modified natural cycle, or In-Vitro Maturation (IVM) cycle (typically involving low follicle count/single puncture)."}
• {"criterion_text":"- Freeze-All' Indication: Cycles where a 'freeze-all' strategy is planned specifically due to a high risk of Ovarian Hyperstimulation Syndrome (OHSS) (defined as > 20 follicles on ultrasound), to avoid confounding pain scores with OHSS symptoms."}

Primary endpoints

• {"endpoint_text":"- Overall intra-procedural pain intensity during OPU, VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure (mean/median or VAS-AUC over time) per SAP.","definition_or_measurement_approach":"VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure: mean/median or VAS-AUC over time as per SAP."}

Secondary endpoints

• {"endpoint_text":"- Patient satisfaction with pain management at ~24 h post-OPU using APS-POQ-R.","definition_or_measurement_approach":"Measured using the APS-POQ-R questionnaire at ~24 hours post-procedure."}
• {"endpoint_text":"- Post-OPU VAS pain at T0 (arrival in recovery), 30 min, 1 h, and discharge.","definition_or_measurement_approach":"VAS pain scores recorded at specified timepoints: arrival in recovery (T0), 30 minutes, 1 hour, and at discharge."}
• {"endpoint_text":"- Rescue analgesic use at home within 24 h (type/amount).","definition_or_measurement_approach":"Recording type and amount of rescue analgesics used at home within 24 hours post-OPU."}
• {"endpoint_text":"- Nausea/vomiting incidence: pre-OPU, immediate post-OPU, 30 min, 1 h, discharge, and at 24 h.","definition_or_measurement_approach":"Incidence of nausea/vomiting recorded at listed timepoints."}
• {"endpoint_text":"- Respiratory depression/other AEs during and immediately after OPU (SpO₂, RR, clinical observation).","definition_or_measurement_approach":"Monitoring SpO₂, respiratory rate and clinical observation for respiratory depression and other adverse events during and immediately after OPU."}
• {"endpoint_text":"- Vaginal bleeding (usual/less/more than usual).","definition_or_measurement_approach":"Assessment of vaginal bleeding categorized as usual/less/more than usual."}
• {"endpoint_text":"- Recovery metrics: time to discharge, procedure duration, number of oocytes retrieved, operator experience level.","definition_or_measurement_approach":"Time to discharge and procedure duration measured; number of oocytes retrieved and operator experience recorded."}
• {"endpoint_text":"- Hormonal/fertility markers: E2/FSH/LH/progesterone and follicle count (2 days pre-OPU); HCG 2 weeks post-ET; clinical pregnancy at ~7 weeks.","definition_or_measurement_approach":"Hormonal markers and follicle count measured pre-OPU; HCG at 2 weeks post-ET; clinical pregnancy assessed at ~7 weeks."}

Belgium

Earliest CTIS Part Ii Submission Date

22-12-2025

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

70

Number Of Sites

1

Number Of Participants

318

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium