NCT07498946

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

Comparison of Ultrasound-Guided Thoracic Paravertebral Block and Bilateral Deep Parasternal Intercostal Plane Block in Adult Patients Undergoing Elective Cardiac Surgery Via Median Sternotomy: A Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Gaziantep City Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Median sternotomy remains the most commonly used surgical approach in adult cardiac surgery and is associated with substantial postoperative pain. Inadequate pain control after sternotomy may lead to increased opioid consumption, delayed mobilization, prolonged extubation time, respiratory complications, and extended intensive care unit or hospital stay. Despite the routine use of multimodal analgesia, postoperative pain after sternotomy continues to be a significant clinical problem. Ultrasound-guided regional analgesia techniques have increasingly been used as part of multimodal pain management strategies in cardiac surgery. Thoracic paravertebral block is one of the established regional techniques that can provide effective hemithoracic analgesia. However, its use may be limited by technical difficulty, dependence on operator experience, and the potential risk of complications. In contrast, deep parasternal intercostal plane block is a more superficial fascial plane block that targets the anterior cutaneous branches of the intercostal nerves, which play an important role in sternotomy-related pain. Although both techniques have shown potential benefit in previous studies, direct comparative data between thoracic paravertebral block and deep parasternal intercostal plane block are limited. This study is designed as a prospective, randomized, controlled, single-center clinical trial in adult patients undergoing elective cardiac surgery via median sternotomy. A total of 80 patients aged 18 to 65 years with American Society of Anesthesiologists physical status II-III will be enrolled. Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to one of two groups: the thoracic paravertebral block group or the bilateral deep parasternal intercostal plane block group. Randomization will be performed using a computer-generated sequence, and group assignments will be concealed in sealed, opaque, sequentially numbered envelopes. All patients will undergo surgery under standard general anesthesia and routine perioperative monitoring according to institutional practice. In addition to standard anesthesia and multimodal analgesia, patients in one group will receive ultrasound-guided thoracic paravertebral block, while patients in the other group will receive ultrasound-guided bilateral deep parasternal intercostal plane block before surgery. All block procedures will be performed by an experienced anesthesiologist. Surgical procedures will be carried out by the same cardiovascular surgical team using the standard median sternotomy technique in order to reduce procedural variability. The primary outcome measure is total opioid consumption during the first 24 hours after surgery. Secondary outcome measures include postoperative pain scores assessed with the Visual Analog Scale at 0, 2, 4, 6, 12, and 24 hours, additional analgesic requirements, analgesia-related adverse effects such as nausea, vomiting, or respiratory depression, and extubation time. Demographic and clinical variables including age, sex, body mass index, ASA class, diabetes mellitus, comorbidities, internal mammary artery preparation, and duration of surgery will also be recorded. The hypothesis of the study is that there will be a significant difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in adult patients undergoing cardiac surgery through median sternotomy. The findings are expected to contribute to the evidence base regarding the comparative effectiveness and clinical applicability of these two active regional analgesia techniques in post-sternotomy pain management.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-04-18
• Primary completion: 2027-04-18
• Completion: 2027-04-18
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Turkey (Türkiye)