About this trial
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Effective control of pain in the early postoperative period is thought to reduce the central sensitisation that drives the transition from acute to chronic pain.
This single-centre, prospective, randomised, patient- and assessor-blinded controlled trial investigates whether an ultrasound-guided bilateral parasternal intercostal nerve block, performed preemptively after induction of general anaesthesia and before surgical incision, reduces the incidence of chronic pain three months after cardiac surgery performed through a median sternotomy.
A total of 132 adults scheduled for elective cardiac surgery will be randomised in a 1:1 ratio to receive either the block plus the institution's standard multimodal analgesia protocol, or the standard protocol alone. The primary endpoint is the incidence of chronic post-sternotomy pain at three months, assessed with the Turkish version of the Brief Pain Inventory - Short Form. Secondary endpoints cover acute pain scores, opioid consumption, postoperative nausea and vomiting, and complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
Scheduled for elective cardiac surgery via median sternotomy
Able to understand and use the Numeric Rating Scale for pain
Willing to participate and able to provide written informed consent
Disqualifiers
Surgery planned by a minimally invasive or thoracoscopic approach
Refusal to participate
Known allergy to the local anaesthetics or analgesics to be used
Chronic opioid use
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Parasternal Intercostal Nerve Block
Procedure/SurgeryPerformed in the supine position after induction of general anaesthesia and before surgical incision, using a 6-15 MHz linear ultrasound probe and a 22 G, 80 mm echogenic block needle.
Bupivacaine 0.25%
Drug0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of chronic post-sternotomy pain at three months
Incidence of chronic post-sternotomy pain at three months
Proportion of participants reporting pain in the sternotomy region three months after surgery, assessed by telephone with the Turkish Brief Pain Inventory - Short Form (BPI-SF). Chronic pain is defined as a reported pain score above 0 on the 0-10 numeric scale, at rest or on movement, persisting for more than three months after the operation.
Locations
Sponsors and contacts
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