The effect of a long lasting pain block for open heart surgery - The PAIN Trial

Efficacy of Perioperative Long-acting Anesthesia by Local Infiltration Following Median Sternotomy - The PAIN Trial - The PAIN Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005886-41-DK

Enrollment

100

Registered

2022-01-24

Start date

2022-06-29

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute postoperative pain after coronary bypass grafting surgery. MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Dexamethasone phosphate hameln Product Name: Dexamethasone phosphate hameln Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE PHOSPHATE CAS Number: 312-93-6 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: Cummulative dose within the first 24 postoperative hours	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Patient-reported pain 2. Time to first mobilization and pain during so 3. Peak flow 4. Ability to ambulate 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 2. Time of first event. 3. 24 hours postoperative 4. 24 hours postoperative 5. at discharge, at 4 weeks and at 6 months	—

Measure

Time frame

Secondary end point(s): 1. Patient-reported pain 2. Time to first mobilization and pain during so 3. Peak flow 4. Ability to ambulate 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 2. Time of first event. 3. 24 hours postoperative 4. 24 hours postoperative 5. at discharge, at 4 weeks and at 6 months

—

Countries

Denmark

Contacts

Public ContactDept. of Cardiothoracic Surgery

Aarhus University Hospital

jonrau@rm.dk004520990948

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026