Using a handheld algometer to predict opioid needs during open-heart surgery
The Usefulness of Preoperative Measurement of the Mechanical Pain Threshold for Predicting Intraoperative Opioid Consumption
NA · Université Libre de Bruxelles · NCT07513974
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Université Libre de Bruxelles (other) |
| Locations | 1 site (Brussels, Anderlecht) |
| Trial ID | NCT07513974 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brussels, Anderlecht
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Surgery Subjects, pain threshold, intra operative opioid consumption, algometer