Postoperative pain treatment after robotically assisted minimally invasive direct coronary artery bypass surgery. MedDRA version: 21.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Morphine HCl
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Morphine HCl
CAS Number: 52-26-6
Other descriptive name: Morphine hydrochloride
Concentration unit: mg/ml mil
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Patient is scheduled for RAMIDCAB surgery. 3. EuroSCORE II = 3 4. BMI = 35. 5. Enrolled in the ERACS program. 6. 18 -75 years of age 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. Participant has a history of or current bleeding disorder, either hereditary or acquired due to antiplatelet or anticoagulatory drugs. 2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol. 3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial. 4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device. 5. Intake of chronic pain medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of our study is to improve perioperative care with the use of a multimodal opioid sparing strategy after minimally invasive cardiac surgery for coronary bypass.;Secondary Objective: Decrease postoperative adverse events and promote quality of life;Primary end point(s): Quality of recovery-40 (QoR-40) assessed 24 hours after extubation will be considered the primary endpoint of this trial;Timepoint(s) of evaluation of this end point: -QoR-40 will be assessed 24 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relevant secondary endpoints considered in the current trial will be: - QoR-40 postoperative day 2 (key-secondary) - Morphine milligramequivalent at 24h and 48h after extubation - Time to extubation - Incidence of PONV - Incidence of pruritus - Incidence of postoperative surgical complications according to the early safety endpoints at 30 days as defined by the VARC-2 criteria - Pain intensity as assessed with the NRS for pain - Extent of sensory block - Hospital length of stay (LOS) - EQ-5D-5L at 3 months (compared to baseline) - Time until rescue analgesics;Timepoint(s) of evaluation of this end point: - Extent of sensory block: 2 hours after extubation - QoR-40: 48hours after extubation - Pain scores will be monitored every 15 min after extubation until the first 2 hours postoperatively, then after 4,6,12,18, 24 and 48 hours post-extubation - VARC-2 criteria: 30 days after surgery - EQ-5D-5L: 90 days after surgery - Every other endpoint will be evaluated once daily until discharge of the patient | — |
Countries
Belgium
Contacts
Public ContactAnesthesiology
University Hospitals Leuven
Outcome results
None listed