Comparison of pain and comfort in patients following cardiac surgery: opioid-morphine managed vs multimodal pain-management. - MONDAY

Phase 1

• Conditions: Cardiac surgery.; MedDRA version: 20.0Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-000515-84-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-15
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- patients undergoing first time cardiac surgery by median sternotomy
- elective surgery or semi-urgent: there needs to be time to provide 8 hours before surgery the intake of pregabalin
- > or = 18 years
- possibility to communicate with the patient to score pain and comfort
- signed informed consent, signed by subject able and willing to provide written informed consent for study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- urgent surgery
- pregnancy and lactation
- hypersensitivity to any of the study medication
- in case of direct postoperative revision the patient is NOT excluded

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare Fentanyl-Tramadol-Paracetamol-Oxycodon regimen to a multimodal painmanagement pregabalin-minimal fentanyl-ketamine-lidocain-dexmedetomidine-paracetamol to determin which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.;Secondary Objective: Not Applicable.;Primary end point(s): The primary endpoint of this study is postoperative pain (at rest, when coughing and at movement) after cardiac surgery. Pain is measured by a NRS-scale if the patient is awake, and by the critical-care pain observation tool (CPOT) in the sedated patient.;Timepoint(s) of evaluation of this end point: At 8h-16h-24h-32h-40h and 48h after cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints include delirium in the direct postoperative phase measured by the ICDSC-score. Also included in the secondary endpoints are: time till extubation, length of hospital stay, length of stay at the ICU department and total comnsumption of pain medication registered in mg/kg.;Timepoint(s) of evaluation of this end point: - time till extubation<br>- length of ICU stay and in general length of hospital stay<br>