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临床试验/NCT07522229
NCT07522229已完成不适用

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

BEDİA MİNE HANEDAN1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Postoperative pain intensity (VAS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Parasternal + Serratus Plane Block

Experimental

Patients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance.

干预措施: Parasternal Intercostal Plane Block (Procedure)

Parasternal Intercostal Plane Block

Experimental

Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery.

干预措施: Parasternal Intercostal Plane Block (Procedure)

Parasternal Intercostal Plane Block

Experimental

Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery.

干预措施: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block (Procedure)

Parasternal + Serratus Plane Block

Experimental

Patients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance.

干预措施: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block (Procedure)

结局指标

主要结局

Postoperative pain intensity (VAS)

时间窗: 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.

次要结局

  • Time to extubation(Postoperative period until extubation.)
  • Length of stay in the intensive care unit (ICU)(From ICU admission after surgery until ICU discharge, up to 30 days)
  • Time to first mobilization(From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days)

研究者

发起方
BEDİA MİNE HANEDAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

BEDİA MİNE HANEDAN

Principal Investigator

Konya City Hospital

研究点 (1)

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