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Completed

NCT Number: NCT07522229

Parasternal vs. Combined Parasternal-Serratus Block in Cardiac Surgery

This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBÜ Konya Şehir Hastanesi

Konya, Turkey (Türkiye)

About this study

Poststernotomy pain after cardiac surgery is a major clinical concern, often leading to impaired respiratory function, limited mobilization, and prolonged intensive care unit (ICU) stay. Although opioids are traditionally used as the mainstay of postoperative analgesia, their side effects-including respiratory depression, nausea, constipation, and delirium-limit their optimal use. Therefore, regional anesthesia techniques that reduce opioid consumption have gained increasing importance in cardiac anesthesia practice.

The parasternal intercostal plane block (PIPB) targets the anterior branches of the thoracic intercostal nerves and has been shown to provide effective analgesia around the sternotomy site. However, PIPB alone may be insufficient for controlling pain originating from lateral chest wall regions, particularly at chest drain insertion sites, which are innervated by the lateral cutaneous branches of the intercostal nerves. To address this limitation, the serratus anterior plane block (SAPB) has been proposed, as it effectively blocks the lateral thoracic dermatomes and thus may provide broader postoperative pain coverage.

This prospective, randomized, single-blind clinical trial is designed to compare the analgesic efficacy of bilateral PIPB alone versus bilateral PIPB combined with unilateral SAPB in adult patients undergoing elective cardiac surgery via sternotomy. A total of 70 patients will be randomly allocated into two groups: Group A will receive bilateral PIPB with standard intravenous morphine, while Group B will receive bilateral PIPB plus unilateral SAPB on the side of chest drain placement. Blocks will be performed under ultrasound guidance using bupivacaine at safe dose limits.

The primary outcome is postoperative pain intensity assessed by the visual analog scale (VAS) at rest and during coughing/movement within the first 24 hours. Secondary outcomes include time to extubation, ICU length of stay, and time to first mobilization. Additional endpoints are rescue opioid requirements and total analgesic consumption within the first 24 hours. We hypothesize that the combined PIPB + SAPB technique will provide superior analgesia, reduce opioid use, and enhance recovery parameters compared with PIPB alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria Adult patients aged 18 years or older Patients scheduled for elective cardiac surgery Patients admitted postoperatively to the intensive care unit Patients who provide written informed consent
  • Exclusion Criteria Known allergy to study medications Chronic opioid use before surgery Severe hepatic or renal failure Neurological or psychiatric disorders affecting pain assessment Inability to provide informed consent

Treatment and study plan

Parasternal Intercostal Plane Block

Procedure

Bilateral parasternal intercostal plane block will be performed under ultrasound guidance at the 3rd and 5th intercostal spaces using 0.25% bupivacaine (total 30 mL). At the end of surgery, intravenous morphine (0.1 mg/kg) will be administered.

Parasternal Intercostal Plane Block + Serratus Anterior Plane Block

Procedure

Bilateral parasternal intercostal plane block will be performed as in Arm 1. In addition, a unilateral serratus anterior plane block will be performed under ultrasound guidance at the 4th-6th intercostal level on the side of chest drain placement, with 0.25% bupivacaine (5-7 mL per injection site, not exceeding 2.5 mg/kg).

Primary outcomes

  1. Postoperative pain intensity (VAS)

    Time frame: 24 hours after surgery

    Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Secondary outcomes

  1. Time to extubation

    Time frame: Postoperative period until extubation.

    The duration (in minutes) from the end of surgery to successful extubation.

  2. Length of stay in the intensive care unit (ICU)

    Time frame: From ICU admission after surgery until ICU discharge, up to 30 days

    Duration of ICU stay measured from admission to the intensive care unit after surgery until transfer to the hospital ward.

  3. Time to first mobilization

    Time frame: From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days

    Time from admission to the intensive care unit after surgery until the first documented patient mobilization attempt.

Other outcomes

  1. Number of rescue opioid administrations

    Time frame: Within the first 24 hours after surgery

    Total number of rescue opioid administrations required for postoperative analgesia.

  2. Total dose of rescue opioids

    Time frame: Within the first 24 hours after surgery

    Total cumulative dose of rescue opioids administered for postoperative analgesia.

Sponsors and collaborators

Lead sponsor

BEDİA MİNE HANEDAN

Other

Registry information

Official study title

Comparison of the Analgesic Effects of Parasternal Intercostal Plane Block Versus Combined Parasternal and Serratus Plane Block After Cardiac Surgery: A Randomized Controlled Trial

Acronym: Hanedan Block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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