The Effect of Remifentanil on the Objectively Measured Pressure Pain Threshold
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pressure pain theshold measured under remifentanil (ultiva®) infusion, Postoperative PCA IV morphine (Sterop®) consumption and adverse events history.
- Who it may be relevant to
- Registry conditions: Pain Threshold, Surgery, Postoperative Pain, Intravenous Anesthesia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement
Overview
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.
Detailed description
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.
Interventions
- Device 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 - Drug 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
Primary outcome measures
- Measurement of the variation in the pressure pain threshold [Time frame: 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.]
Secondary outcome measures (1)
- Correlation between preoperative pain threshold and total postoperative morphine consumption [Time frame: From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.]
Eligibility criteria
Inclusion criteria
- Adult patients who are able to volunteer
- ASA 1, 2and 3
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- HUB Erasme — Brussels
Identifiers
NCT: NCT07568405 · HUB2025549