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Recruiting 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

No phase Interventional Cardiac Surgery Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measure of the minimal pain threshold with an algometer.
Who it may be relevant to
Registry conditions: Cardiac Surgery Subjects. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Erasme Hospital — Brussels

Identifiers

NCT: NCT07513974 · HUB2025080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗