Using a handheld algometer to predict opioid needs during open-heart surgery
Official title: The Usefulness of Preoperative Measurement of the Mechanical Pain Threshold for Predicting Intraoperative Opioid Consumption
Run by Université Libre de Bruxelles · NCT07513974 · Data updated 2026-11-12
This will try to see if a preoperative pain threshold measured with a handheld algometer can predict how much opioid pain medicine patients need during and after elective cardiac surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Université Libre de Bruxelles Academic / other |
| Locations | 1 site (Brussels, Anderlecht) |
| Status | Recruiting |
| Started | January 24, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07513974 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ASA 3 adults scheduled for elective cardiac surgery by thoracotomy or sternotomy who are not pregnant, do not have chronic pain or regular opioid use, have BMI ≤30, and lack severe renal, hepatic, or uncontrolled cardiac/pulmonary disease.
✕Probably not a fit
Patients with chronic pain or regular analgesic/opioid use, BMI over 30, severe organ dysfunction, emergency surgery, or those likely to have major perioperative bleeding or complications are unlikely to benefit from the study's predictive approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Before elective cardiac operations performed by thoracotomy or sternotomy, investigators will measure each patient's mechanical pain threshold using an algometer. Anesthesia and surgical care will be highly standardized and intraoperative and postoperative opioid use will be recorded. The study will test for correlations between the objective preoperative threshold and perioperative opioid consumption. Patients with major comorbidities, chronic pain, regular analgesic use, or BMI >30 are excluded to reduce confounding.
Why it matters
Potential benefit: If successful, this approach could let clinicians personalize opioid dosing for cardiac surgery patients using a quick preoperative measurement, potentially reducing under- or over-treatment of pain.
How similar studies have gone: Similar studies using algometer-measured pain thresholds have shown mixed but promising correlations with perioperative opioid needs in other surgical groups, so the method is somewhat supported but not yet standard practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA 3 patients with scheduled cardiac surgery by thoracotomy or sternotomy Exclusion Criteria: * 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. * 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.
Where it's running
-
Erasme Hospital
Brussels, Anderlecht, Belgium Recruiting
Study contacts
- Principal investigator: IONUT TABOLCEA, Doctor — Erasme University Hospital
- Study coordinator: IONUT TABOLCEA, Doctor
- Email: Ionut.tabolcea@hubruxelles.be
- Phone: +32 488 72 00 46
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.