Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery

NCT07818512 | Not Yet Recruiting

• 2 other identifiers: 2026/3102026-18-08
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Chronic Post-Sternotomy Pain; Chronic Postoperative Pain; CABG; Sternotomy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of chronic post-sternotomy pain at three months

  3 months after surgery

• Incidence of chronic post-sternotomy pain at three months

  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.

  3 months after surgery

Study Arms (2)

PINB Group

EXPERIMENTAL

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.

Procedure: Ultrasound-Guided Parasternal Intercostal Nerve Block; Drug: Bupivacaine 0.25%

Control Group

NO INTERVENTION

No regional block is performed. Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group.

Interventions

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.

PINB Group

Bupivacaine 0.25% DRUG

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

PINB Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Related Publications (1)

• Kleiman AM, Sanders DT, Nemergut EC, Huffmyer JL. Chronic Poststernotomy Pain: Incidence, Risk Factors, Treatment, Prevention, and the Anesthesiologist's Role. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):698-708. doi: 10.1097/AAP.0000000000000663.

  PMID: 28937533 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Ilayda Kalyoncu Karahan, MD

CONTACT

00905325105014; ilaydaakalyoncu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the investigator performing postoperative and three-month assessments are blinded to allocation. The anaesthesiologist performing the block cannot be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor (MD), Department of Anesthesiology and Reanimation

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

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): November 25, 2027
• Study Completion (Estimated): August 25, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share