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

NCT07498946 | Not Yet Recruiting

• 1 other identifier: 371
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Cardiac Surgery; Postoperative Pain After Cardiac Surgery Via Median Sternotomy

Keywords

Postoperative Pain; Cardiac Surgery; Median Sternotomy; Thoracic Paravertebral Block; Deep Parasternal Intercostal Plane Block; Regional Analgesia; Ultrasound-Guided Nerve Block; Opioid Consumption; Visual Analog Scale

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption in the First 24 Hours After Surgery

  Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the two groups.

  First 24 hours after surgery

Secondary Outcomes (4)

• Postoperative Pain Scores Assessed by Visual Analog Scale

  0, 2, 4, 6, 12, and 24 hours after surgery

• Additional Analgesic Requirement

  First 24 hours after surgery

• Analgesia-Related Adverse Effects

  First 24 hours after surgery

• Extubation Time

  During the postoperative period, up to 24 hours after surgery

Study Arms (2)

Thoracic Paravertebral Block Group

ACTIVE COMPARATOR

Participants undergoing elective cardiac surgery via median sternotomy will receive ultrasound-guided thoracic paravertebral block before surgery in addition to standard general anesthesia and routine multimodal analgesia.

Procedure: Thoracic paravertebral block (TPVB)

Bilateral Deep Parasternal Intercostal Plane Block Group

ACTIVE COMPARATOR

Participants undergoing elective cardiac surgery via median sternotomy will receive ultrasound-guided bilateral deep parasternal intercostal plane block before surgery in addition to standard general anesthesia and routine multimodal analgesia.

Procedure: Bilateral Deep Parasternal Intercostal Plane Block

Interventions

Thoracic paravertebral block (TPVB) PROCEDURE

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

Thoracic Paravertebral Block Group

Bilateral Deep Parasternal Intercostal Plane Block PROCEDURE

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.

Bilateral Deep Parasternal Intercostal Plane Block Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep Şehir Hastanesi

Gaziantep, Sahinbey, Turkey (Türkiye)

Location

Related Publications (2)

• Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26.

  PMID: 38537393 RESULT

• Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.

  PMID: 38148266 RESULT

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

Burak Cemil BALIK, MD

CONTACT

05339545102; cburakbalik@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative outcome assessments, including Visual Analog Scale pain scores, will be performed by research staff/nurses blinded to group allocation. The anesthesiologist performing the block procedure will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Model Details: Participants will be randomized in a 1:1 ratio to 2 parallel groups receiving either thoracic paravertebral block or bilateral deep parasternal intercostal plane block.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): April 18, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)