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 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery Subjects
• Intervention / Treatment: Device: Measure of the minimal pain threshold with an algometer

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IONUT TABOLCEA, Doctor; Phone Number: +32 488 72 00 46; Email: Ionut.tabolcea@hubruxelles.be
• Study Contact Backup: Name: NATHAN ASSERAF; Phone Number: +33695951361; Email: nathan.asseraf@ulb.be

Study Locations

• Belgium
  • Anderlecht
    • Brussels, Anderlecht, Belgium, 1070
      • Recruiting
      • Erasme Hospital
      • Contact: Dr. IONUT TABOLCEA; Phone Number: +32 488 72 00 46; Email: Ionut.tabolcea@hubruxelles.be
      • Contact: NATHAN ASSERAF; Phone Number: +33 6 95 95 13 61; Email: nathan.asseraf@ulb.be
      • Principal Investigator: IONUT TABOLCEA, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The measure of the minimal pain threshold is taken the day before the cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of opioid administration during hospital stay, up to 6 days after the enrollment

Collaborators and Investigators

• Sponsor: Université Libre de Bruxelles
• Investigators: Principal Investigator: IONUT TABOLCEA, Doctor, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain threshold; algometer; intra operative opioid consumption
• Other Study ID Numbers: HUB2025080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD collected throughout the trial
• IPD Sharing Time Frame: Beginning 1 month after publication with no end date
• IPD Sharing Access Criteria: reserchers working in the same area of research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No