Cardiac Surgery SubjectsNCT07513974
Objective Measurement of the Mechanical Pain Threshold With an Algometer for Predicting Intraoperative Opioid Consumption in Patients Who Will be Operate by Thoracotomy and Sternotomy in Cardiac Surgery
A study testing Measure of the minimal pain threshold with an algometer in people with Cardiac Surgery Subjects, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids. The objective of the study is to try to predict a patient's analgesic needs based on their objectively determined preoperative pain threshold. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery Subjects
- What is being tested?
- Measure of the minimal pain threshold with an algometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jan 2026to 15 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA 3 patients with scheduled cardiac surgery by thoracotomy or sternotomy
Who cannot join
- Patient refusal,
- A body mass index (BMI) > 30 kg/m²,
- Allergies to any medication used in typical cardiac anesthesia,
- Chronic pain or regular use of analgesics,
- Severe ventricular dysfunction, pulmonary hypertension, poorly controlled arhythmia,
- Non-elective surgery.
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- Patients enrolled in another study protocol within the previous 3 months,
- Pregnant or breastfeeding patients,
- Patients with severe renal or hepatic impairment.
- Patients for whom the study will be stopped in the event of blood loss greater than or equal to one liter, or for any other severe perioperative surgical complication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital
Brussels, Anderlecht, 1070
Dr. IONUT TABOLCEA, +32 488 72 00 46, Ionut.tabolcea@hubruxelles.be
NATHAN ASSERAF, +33 6 95 95 13 61, nathan.asseraf@ulb.be
About this study
Official title: The Usefulness of Preoperative Measurement of the Mechanical Pain Threshold for Predicting Intraoperative Opioid Consumption
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids.
The objective of the study is to try to predict a patient's analgesic needs based on their objectively determined preoperative pain threshold.
The investigators will include patients scheduled for elective cardiovascular surgery.
The investigators will investigate the correlation between the preoperative pain threshold and intraoperative/postoperative opioid consumption in a highly standardized anesthesia setting.
- Conditions
- Cardiac Surgery Subjects
- Being tested
- Measure of the minimal pain threshold with an algometer
- Keywords
- pain threshold, intra operative opioid consumption, algometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of the minimal pain threshold with an algometerDevice
The measure of the minimal pain threshold is taken the day before the cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| pain threshold arm | Other | In this arm, patients get a measure of their minimal pain threshold in the preoperative time, that is the only intervention they get in addition of the classic care support Receives: Device: Measure of the minimal pain threshold with an algometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the pressure pain threshold and the consumption of opioid during and after the surgery
After the measure of the minimal pain threshold the day before the surgery, the investigators look at the quantity of Remifentanil which has been given to the patient during the surgery. Then they will look for a correlation
Measured: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment
Secondary outcomes (1)
Correlation between the pain threshold and the consumption of morphine during the post-operative time
After the measure of the minimal pain threshold the day before the surgery, the investigators look at the quantity of morphine which has been administrated by a PCA (Intravenous Patient-Controlled Analgesia (IV-PCA) with morphine) to the patient during the post-operative time. Then they are looking for a correlation.
Measured: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start24 Jan 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery SubjectsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASSERAF NATHAN, Université Libre de Bruxelles
- Investigators
- IONUT TABOLCEA, Doctor, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513974
- Sponsor's protocol ID
- HUB2025080
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Preoperative Measurement of the Mechanical Pain Threshold for Predicting Intraoperative Opioid Consumption
- ClinicalTrials.gov ID
- NCT07513974
- Acronym / sponsor ID
- HUB2025080
- Conditions
- Cardiac Surgery Subjects
- Keywords
- pain threshold, intra operative opioid consumption, algometer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 7 Apr 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.
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids.
The objective of the study is to try to predict a patient's analgesic needs based on their objectively determined preoperative pain threshold.
The investigators will include patients scheduled for elective cardiovascular surgery.
The investigators will investigate the correlation between the preoperative pain threshold and intraoperative/postoperative opioid consumption in a highly standardized anesthesia setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pain threshold arm | Other | Device: Measure of the minimal pain threshold with an algometerIn this arm, patients get a measure of their minimal pain threshold in the preoperative time, that is the only intervention they get in addition of the classic care support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 3 patients with scheduled cardiac surgery by thoracotomy or sternotomy
Key exclusion criteria (10 listed)
- Patient refusal,
- A body mass index (BMI) > 30 kg/m²,
- Allergies to any medication used in typical cardiac anesthesia,
- Chronic pain or regular use of analgesics,
- Severe ventricular dysfunction, pulmonary hypertension, poorly controlled arhythmia,
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 |
|---|---|---|
| Measure of the minimal pain threshold with an algometerThe measure of the minimal pain threshold is taken the day before the cardiac surgery | Device | pain threshold arm |
Primary outcome
Correlation between the pressure pain threshold and the consumption of opioid during and after the surgery
Time frame: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment
After the measure of the minimal pain threshold the day before the surgery, the investigators look at the quantity of Remifentanil which has been given to the patient during the surgery. Then they will look for a correlation
1 secondary outcome
Correlation between the pain threshold and the consumption of morphine during the post-operative time
Time frame: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment
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 7 Apr 2026.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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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.
IONUT TABOLCEA, Doctor principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of the minimal pain threshold with an algometer in people with Cardiac Surgery Subjects, 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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Apr 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?
Contact IONUT TABOLCEA, Doctor (+32 488 72 00 46, Ionut.tabolcea@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the pressure pain threshold and the consumption of opioid during and after the surgery (time frame: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment). 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 7 Apr 2026.