The effect of a long lasting pain block for open heart surgery - The PAIN Trial
- Conditions
- Acute postoperative pain after coronary bypass grafting surgery.MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2021-005886-41-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Patients undergoing first-time, non-emergent coronary artery bypass grafting including harvest of the left internal mammary artery through a median sternotomy
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Emergent treatment (<24 hours)
Prior sternotomy or cardiac surgery
Concurrent heart surgery other than arrythmia surgery (i.e lung vein ablation and/or left appendage closure)
Daily use of opioids within the last 6 month prior to enrollment
Preoperative regular use of corticosteroids
Known allergy or intolerance to any of the included drugs
Woman of childbearing age without negative pregnancy test and nursing women
Any known condition that might interfere with the used drugs
Known impaired kidney function (defined as eGFR < 30 ml/min)
Active participation in another interventional trial with potential impact on postoperative pain and/or respiratory function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of long-acting local infiltration anesthesia in patients undergoing coronary bypass grafting through sternotomy. ;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint is accumulated opioid consumption <br>;Timepoint(s) of evaluation of this end point: Cummulative dose within the first 24 postoperative hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Patient-reported pain <br>2. Time to first mobilization and pain during so <br>3. Peak flow <br>4. Ability to ambulate <br>5. Requirement of opioid medication;Timepoint(s) of evaluation of this end point: 1. at rest and coughing after extubation and within the first 24 hours after surgery <br>2. Time of first event.<br>3. 24 hours postoperative <br>4. 24 hours postoperative <br>5. at discharge, at 4 weeks and at 6 months