ClinicalTrials.gg
RecruitingNCT07513974Updated Apr 7, 2026

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

An interventional study of Measure of the minimal pain threshold with an algometer in Cardiac Surgery Subjects, sponsored by Université Libre de Bruxelles. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cardiac Surgery Subjects

Keywords

  • pain threshold
  • intra operative opioid consumption
  • algometer
03

In context

Lead sponsor

Université Libre de Bruxelles is the lead sponsor of 45 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ASA 3 patients with scheduled cardiac surgery by thoracotomy or sternotomy

Exclusion criteria

Exclusion Criteria:

  • Patient refusal,
  • A (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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    pain threshold arm

    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

    Device: Measure of the minimal pain threshold with an algometer

Interventions

  • DeviceMeasure of the minimal pain threshold with an algometer

    The measure of the minimal pain threshold is taken the day before the cardiac surgery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — all IPD collected throughout the trial

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Beginning 1 month after publication with no end date

Access criteria: reserchers working in the same area of research

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2026
First posted
Apr 7, 2026
StartActual
Jan 24, 2026
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 15, 2026
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07513974
Lead sponsor
Université Libre de Bruxelles
Responsible party
ASSERAF NATHAN (Medicine student, Université Libre de Bruxelles) — Principal investigator
First posted
Apr 7, 2026
Start date
Jan 24, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Apr 7, 2026

Study contacts

IONUT TABOLCEA, Doctor
Contact
Ionut.tabolcea@hubruxelles.be
+32 488 72 00 46
NATHAN ASSERAF
Contact
nathan.asseraf@ulb.be
+33695951361
IONUT TABOLCEA, Doctor
principal investigator · Erasme University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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