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NCT Number: NCT07513974

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

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.

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Key information

Conditions

Cardiac Surgery Subjects

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measure of the minimal pain threshold with an algometer

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

IONUT TABOLCEA, Doctor

CONTACT

[email protected]

+32 488 72 00 46

NATHAN ASSERAF

CONTACT

[email protected]

+33695951361

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

The Usefulness of Preoperative Measurement of the Mechanical Pain Threshold for Predicting Intraoperative Opioid Consumption

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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