Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery

NCT07498946 · tracked via the Priya Life Science Turkey tracker

Sponsor

Gaziantep City Hospital

Phase

Not applicable

Started

2026-04-18

Last updated

2026-03-27

Condition(s) studied

Postoperative PainCardiac SurgeryPostoperative Pain After Cardiac Surgery Via Median Sternotomy

Investigational drug(s) / intervention(s)

Thoracic paravertebral block (TPVB)Bilateral Deep Parasternal Intercostal Plane Block

Thoracic paravertebral block (TPVB): Ultrasound-guided thoracic paravertebral block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

Bilateral Deep Parasternal Intercostal Plane Block: Ultrasound-guided bilateral deep parasternal intercostal plane block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

Study summary

Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and contribute to respiratory complications and longer hospital stay. Regional analgesia techniques may help improve pain management and reduce opioid requirements after surgery.

This study is a prospective, randomized, single-center clinical trial that will compare two ultrasound-guided regional analgesia techniques in adult patients undergoing elective cardiac surgery through median sternotomy: thoracic paravertebral block and bilateral deep parasternal intercostal plane block. A total of 80 patients will be randomly assigned in a 1:1 ratio to receive one of these two blocks in addition to standard general anesthesia and routine multimodal analgesia.

The main objective of the study is to compare the effects of these two techniques on total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, need for additional analgesics, analgesia-related side effects such as nausea, vomiting, or respiratory depression, and extubation time. Pain will be assessed using a visual analog scale at predefined time points during the first 24 postoperative hours.

The study hypothesis is that there will be a clinically meaningful difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in patients undergoing cardiac surgery via median sternotomy. The results of this study may help guide the selection of the most appropriate regional analgesia technique for pain control after sternotomy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: Age 18 to 65 years Scheduled for elective cardiac surgery via median sternotomy American Society of Anesthesiologists physical status II or III Planned to undergo surgery under general anesthesia Able to comply with postoperative pain assessment using the Visual Analog Scale Able to provide written informed consent Exclusion Criteria: Emergency cardiac surgery Cardiac surgery performed through an approach other than median sternotomy Redo sternotomy Local infection or skin disruption at the planned block site Known allergy or hypersensitivity to amide local anesthetics Clinically significant coagulopathy or antiplatelet/anticoagulant treatment preventing safe regional block according to institutional protocol Clinically unstable condition or high risk for pleural complications that would make the block unsafe Chronic opioid use or chronic pain syndrome Advanced musculoskeletal disease or deformity that may interfere with pain assessment Neurological or psychiatric disorder causing inability to comply with postoperative pain assessment Cognitive impairment preventing reliable pain assessment Clinically significant peripheral neuropathy or other neurosensory condition affecting pain perception Pregnancy or breastfeeding Severe pulmonary disease, including advanced chronic obstructive pulmonary disease or severe restrictive lung disease Anticipated inability to comply with the study protocol

Primary outcome measure(s)

Total Opioid Consumption in the First 24 Hours After Surgery — First 24 hours after surgery
Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the two groups.

Trial sites (1)

Facility	City	Region	Status
Gaziantep Şehir Hastanesi	Gaziantep	Sahinbey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07498946 on ClinicalTrials.gov ↗ ← All trials in Turkey