Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Parasternal Intercostal Nerve Block

    Procedure/Surgery

    Performed 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%

    Drug

    0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: PINB GroupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of chronic post-sternotomy pain at three months

Time frame
3 months after surgery
2

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.

Time frame
3 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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