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Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07818512
Acronym
PINB-CPSP
Enrollment
174
Registered
2026-09-14
Start date
2026-08-25
Completion date
2028-08-25
Last updated
2026-09-16

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

Conditions

CABG, Chronic Postoperative Pain, Chronic Post-Sternotomy Pain, Sternotomy

Keywords

parasternal intercostal nerve block, PINB, chronic post-sternotomy pain

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREUltrasound-Guided Parasternal Intercostal Nerve Block

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.

DRUGBupivacaine 0.25%

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

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and the investigator performing postoperative and three-month assessments are blinded to allocation. The anaesthesiologist performing the block cannot be blinded.

Intervention model description

Two parallel groups in a 1:1 ratio: preemptive ultrasound-guided bilateral parasternal intercostal nerve block plus standard analgesia, versus standard analgesia alone.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of chronic post-sternotomy pain at three months3 months after surgery

Contacts

CONTACTIlayda Kalyoncu Karahan, MD
ilaydaakalyoncu@gmail.com00905325105014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026