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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ilayda Kalyoncu Karahan, MD
- Telefoonnummer: 00905325105014
- E-mail: ilaydaakalyoncu@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Incidence of chronic post-sternotomy pain at three months
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026/310
- 2026-18-08 (Andere identificatie: Bakirkoy Dr. Sadi Konuk Training and Research Hospital Clinical Research Ethics Committee)
Plan Individuele Deelnemersgegevens (IPD)
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