Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery (PINB-CPSP)
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
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ilayda Kalyoncu Karahan, MD
- Telefonní číslo: 00905325105014
- E-mail: ilaydaakalyoncu@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: PINB Group
After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol.
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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.
0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block.
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Žádný zásah: Control Group
No regional block is performed.
Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Incidence of chronic post-sternotomy pain at three months
Časové okno: 3 months after surgery
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3 months after surgery
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Incidence of chronic post-sternotomy pain at three months
Časové okno: 3 months after surgery
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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.
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3 months after surgery
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026/310
- 2026-18-08 (Jiný identifikátor: Bakirkoy Dr. Sadi Konuk Training and Research Hospital Clinical Research Ethics Committee)
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