The Effect of Remifentanil on the Objectively Measured Pressure Pain Threshold

Официальное название

L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement

Обзор

It is a clinical study investigating the relationship between objectively measured pain threshold and the need for escalating doses of remifentanyl opioids. This study is expected to include approximately 40 participants. The aim of the study is to objectively measure the analgesic effect of an increasing dose of opioids just before anesthesia.

Подробное описание

This is a prospective interventional study. Participants will undergo controlled pressure stimulation using an Algometer device to determine their pressure pain threshold (PPT).

Pressure pain threshold will be assessed at baseline (0 ng/mL) and during stepwise increasing target-controlled intravenous remifentanil concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.

Investigators hypothesize that increasing plasma concentrations of remifentanil will be associated with a corresponding increase in pressure pain threshold.

In addition, postoperative analgesic consumption will be recorded following surgery. This will allow the investigators to explore a potential association between intraoperative pressure pain threshold modulation and postoperative pain outcomes or analgesic requirements.

Вмешательства

• Устройство Pressure pain theshold measured under remifentanil (ultiva®) infusion
  Upon arrival in the operating room, the patient will undergo standard monitoring, including non-invasive blood pressure, electrocardiography (ECG), pulse oximetry (SpO₂), bispectral index (BIS™), and train-of-four (TOF) monitoring. An intravenous (IV) line will be placed, and crystalloid infusion will be initiated. Mechanical pain threshold will then be assessed using a Medoc algometer. Measurements will be performed on the dorsum of the non-dominant hand. Four measurements will be obtained at
• Препарат Postoperative PCA IV morphine (Sterop®) consumption and adverse events history
  At the end of the surgical procedure, intravenous acetaminophen 1 g and a 4 mg morphine bolus will be administered. Upon arrival in the post-anesthesia care unit (PACU), pain will be assessed using the visual analogue scale (VAS). During the first 24 postoperative hours, analgesia will be provided via a patient-controlled analgesia (PCA) pump delivering 2 mg intravenous HCL morphine (Sterop®) boluses on demand. The PCA settings will follow a 2/10/20 regimen: 2 mg morphine per demand dose, a 10

Первичные конечные точки

• Measurement of the variation in the pressure pain threshold [Срок оценки: Measurement of the mechanical pressure pain threshold will be initiated upon the participant's arrival in the operating room. The procedure is expected to last approximately 10-15 minutes and will be followed by induction of anesthesia.]

Вторичные конечные точки (1)

• Correlation between preoperative pain threshold and total postoperative morphine consumption [Срок оценки: From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.]

Критерии участия

Критерии включения

• Adult patients who are able to volunteer
• ASA 1, 2and 3

Критерии исключения

• Refusal to participate;

• Body mass index (BMI) > 30 kg/m²;
• Allergy to any medication used for anesthesia;
• Chronic pain or regular use of analgesics;
• Severe ventricular dysfunction, pulmonary hypertension, or uncontrolled arrhythmia;
• Non-elective surgery;
• Participation in another study within the last 3 months;
• Pregnancy or breastfeeding;
• Severe renal or hepatic impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Бельгия · 1 центр

• HUB Erasme — Brussels

Идентификаторы

NCT: NCT07568405 · HUB2025549

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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