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NCT Number: NCT07818512

Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery

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 174 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.

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Key information

Conditions

Chronic Postoperative Pain CABG Chronic Post-Sternotomy Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sternotomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Design and setting. The trial will be conducted in the Department of Anesthesiology and Reanimation, University of Health Sciences Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Eligible patients will be identified at the preoperative anaesthesia assessment and written informed consent will be obtained.

Randomisation and blinding. Participants will be allocated 1:1 using sequentially numbered, opaque, sealed envelopes prepared in advance. Patients and the investigator performing postoperative assessments will be unaware of group assignment; the anaesthesiologist performing the block cannot be blinded.

Intervention. In the block group, after induction of general anaesthesia and before surgical incision, a bilateral parasternal intercostal nerve block will be performed in the supine position with a high-frequency linear ultrasound probe (6-15 MHz) and a 22 G, 80 mm echogenic block needle.

Anaesthetic and analgesic management, identical in both groups.

Assessments. Pain is scored with the Numeric Rating Scale at rest and on movement at 1, 6, 12 and 24 hours after extubation. Opioid consumption, postoperative nausea and vomiting and any complications are recorded. At three months patients are contacted by telephone and assessed with the Brief Pain Inventory - Short Form, validated in Turkish by Ataman and colleagues.

Sample size. The calculation is based on the primary endpoint. 87 participants per group will be enrolled, for a total of 174.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Coagulopathy
Infection at the planned block site
Pregnancy or lactation
Inability to communicate or to score pain reliably
Psychiatric or neurological condition preventing reliable completion of the BPI-SF and NRS assessments

Treatment and study plan

Ultrasound-Guided Parasternal Intercostal Nerve Block

Procedure

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.

Primary outcomes

Incidence of chronic post-sternotomy pain at three months

Time frame: 3 months after surgery
Incidence of chronic post-sternotomy pain at three months

Time frame: 3 months after surgery

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilayda Kalyoncu Karahan, MD

CONTACT

[email protected]

00905325105014

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Effect of Ultrasound-Guided Preemptive Parasternal Intercostal Nerve Block on the Incidence of Chronic Pain After Cardiac Surgery Via Sternotomy: A Prospective Randomized Controlled Trial

Acronym: PINB-CPSP

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Sep 14, 2026
Registry last updated: Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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