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Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery

Study acronym: PINB-CPSP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 24% 174 → 132 participants
See other at-risk trials from Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Record History

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  1. Notable Start date pushed from Aug 25, 2026 to Sep 28, 2026
    • Enrollment reduced: 174 → 132 participants
    • Study description expanded, about 2 words
  2. Minor Enrollment increased: 132 → 174 participants
    • Eligibility criteria shortened, about 13 words
    • Study description shortened, about 1 word
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07818512
Lead Sponsor Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Conditions
(from sponsor)
Chronic Postoperative Pain, Chronic Post-Sternotomy Pain, CABG, Sternotomy
Related terms Postoperative Pain
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov