Pain ThresholdNCT07568405
The Effect of Remifentanil on the Objectively Measured Pressure Pain Threshold
A study testing Pressure pain theshold measured under remifentanil (ultiva®) infusion and Postoperative PCA IV morphine (Sterop®) consumption and adverse events history in people with Pain Threshold and Surgery, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold, Surgery, Postoperative Pain
- What is being tested?
- Pressure pain theshold measured under remifentanil (ultiva®) infusion and Postoperative PCA IV morphine (Sterop®) consumption and adverse events history
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who are able to volunteer
- ASA 1, 2and 3
Who cannot join
- 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;
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- Participation in another study within the last 3 months;
- Pregnancy or breastfeeding;
- Severe renal or hepatic impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement
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.
Read the 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.
- Conditions
- Pain Threshold, Surgery, Postoperative Pain, Intravenous Anesthesia
- Being tested
- Pressure pain theshold measured under remifentanil (ultiva®) infusion, Postoperative PCA IV morphine (Sterop®) consumption and adverse events history
- Keywords
- pain threshold, posoperative pain, remifentanil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure pain theshold measured under remifentanil (ultiva®) infusionDevice
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 different target plasma concentrations of remifentanil(Ultiva®): 0, 1, 2, and 3 ng/mL. Remifentanil will be administered using a target-controlled infusion (TCI) system based on the Minto pharmacokinetic model.
Following completion of these measurements, standardized intravenous anesthesia will be induced and maintained using propofol (propolipid®), remifentanil, and rocuronium (B.Braun®).
Total perioperative consumption of remifentanil and propofol will be recorded.
Postoperative PCA IV morphine (Sterop®) consumption and adverse events historyDrug
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-minute lockout interval, and a maximum dose of 20 mg over 4 hours.
The use of acetaminophen as adjunct analgesia is permitted; however, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), piritramide, and magnesium are prohibited.
Pain scores (VAS) will be reassessed at 12 and 24 hours postoperatively.
All adverse events (e.g., nausea, delirium) will be monitored and recorded during the 24-hour postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption | Experimental | This is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored.
Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.
Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented. Receives: Device: Pressure pain theshold measured under remifentanil (ultiva®) infusion; Drug: Postoperative PCA IV morphine (Sterop®) consumption and adverse events history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the variation in the pressure pain threshold
Change in mechanical pain threshold measured objectively using an algometer (AlgoMed®) at increasing plasma concentrations of remifentanil (0, 1, 2, and 3 ng/mL) during the preoperative period.
The pain threshold is defined as the pressure (in kilopascals) at which the patient first reports pain during a standardized mechanical stimulus.
Measured: 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 outcomes (1)
Correlation between preoperative pain threshold and total postoperative morphine consumption
Correlation between preoperative pain threshold and total postoperative morphine consumption (particularly within the first 24 hours using patient-controlled analgesia).
Postoperative pain scores assessed using standard pain scales in the post-anesthesia care unit.
Intraoperative opioid (remifentanil) consumption in a standardized anesthesia setting.
Post operative opioid (PCA, morphine) consumption recorded within the first 24H post surgery.
Measured: From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start26 Jan 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaud Bollens, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568405
- Sponsor's protocol ID
- HUB2025549
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement
- ClinicalTrials.gov ID
- NCT07568405
- Acronym / sponsor ID
- HUB2025549
- Conditions
- Pain Threshold, Surgery, Postoperative Pain, Intravenous Anesthesia
- Keywords
- pain threshold, posoperative pain, remifentanil
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption | Experimental | Device: Pressure pain theshold measured under remifentanil (ultiva®) infusion, Drug: Postoperative PCA IV morphine (Sterop®) consumption and adverse events historyThis is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored. Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions. Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who are able to volunteer
- ASA 1, 2and 3
Key exclusion criteria (9 listed)
- Refusal to participate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure pain theshold measured under remifentanil (ultiva®) infusionUpon 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 different target plasma concentrations of remifentanil(Ultiva®): 0, 1, 2, and 3 ng/mL. Remifentanil will be administered using a target-controlled infusion (TCI) system based on the Minto pharmacokinetic model. Following completion of these measurements, standardized intravenous anesthesia will be induced and maintained using propofol (propolipid®), remifentanil, and rocuronium (B.Braun®). Total perioperative consumption of remifentanil and propofol will be recorded. | Device | Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption |
| Postoperative PCA IV morphine (Sterop®) consumption and adverse events historyAt 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-minute lockout interval, and a maximum dose of 20 mg over 4 hours. The use of acetaminophen as adjunct analgesia is permitted; however, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), piritramide, and magnesium are prohibited. Pain scores (VAS) will be reassessed at 12 and 24 hours postoperatively. All adverse events (e.g., nausea, delirium) will be monitored and recorded during the 24-hour postoperative period. | Drug | Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption |
Primary outcome
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.
Change in mechanical pain threshold measured objectively using an algometer (AlgoMed®) at increasing plasma concentrations of remifentanil (0, 1, 2, and 3 ng/mL) during the preoperative period. The pain threshold is defined as the pressure (in kilopascals) at which the patient first reports pain during a standardized mechanical stimulus.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure pain theshold measured under remifentanil (ultiva®) infusion and Postoperative PCA IV morphine (Sterop®) consumption and adverse events history in people with Pain Threshold and Surgery, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.