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临床试验/NCT07737132
NCT07737132尚未招募不适用

Comparison of Postoperative Analgesic Efficacy of Superior Posterior Serratus Intercostal Plane Block (SPSIP) and Anterior Serratus Plane Block in Modified Radical Mastectomy Surgery

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey0 个研究点目标入组 70 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
Postoperative pain intensity

研究概览

简要总结

Postoperative pain following modified radical mastectomy remains a significant clinical challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited.

This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.

详细描述

Breast cancer surgery, particularly modified radical mastectomy, is frequently associated with moderate to severe postoperative pain. Inadequate pain control may impair respiratory function, delay mobilization, prolong hospital stay, increase opioid consumption, and contribute to the development of persistent postsurgical pain. Therefore, effective multimodal analgesia incorporating regional anesthesia techniques has become an important component of perioperative care in breast surgery.

Among ultrasound-guided fascial plane blocks, the serratus anterior plane block (SAPB) has been widely adopted because of its ability to block the lateral cutaneous branches of the intercostal nerves, resulting in reduced postoperative pain scores and opioid requirements. More recently, the serratus posterior superior intercostal plane block (SPSIPB) has been introduced as a novel interfascial block that may provide broader thoracic dermatomal spread through injection between the serratus posterior superior and intercostal muscles. Although early clinical reports have demonstrated promising analgesic efficacy, comparative evidence between SPSIPB and SAPB in breast surgery remains limited.

This study is designed as a prospective, randomized, double-blind, single-center clinical trial to compare the analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-III who meet the eligibility criteria will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio using sealed-envelope allocation to receive either ultrasound-guided SPSIPB or SAPB before induction of general anesthesia. Both blocks will be performed using 30 mL of 0.25% bupivacaine under standardized ultrasound guidance by experienced anesthesiologists.

General anesthesia and postoperative analgesic management will be standardized for all participants. Intraoperative anesthetic management will include propofol, fentanyl, rocuronium, sevoflurane, and remifentanil according to institutional practice. Following surgery, all patients will receive standardized multimodal analgesia consisting of intravenous paracetamol, tramadol patient-controlled analgesia (PCA), and rescue analgesics when clinically indicated.

The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS) at predefined postoperative time points. Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV) scores, rescue analgesic requirements, quality of recovery measured using the QoR-40 questionnaire at 24 hours, block-related complications, and other postoperative adverse events.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants and postoperative outcome assessors will be blinded to treatment allocation. The anesthesiologist performing the block cannot be blinded because of the nature of the intervention and will not participate in postoperative data collection or outcome assessment.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18 to 65 years.
  • Scheduled for elective modified radical mastectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) <35 kg/m².
  • Normal coagulation profile (including INR and platelet count).
  • Normal liver and renal function tests.
  • Able to understand the study procedures and provide written informed consent.

排除标准

  • Known allergy or hypersensitivity to local anesthetics.
  • Coagulation disorders or bleeding diathesis.
  • Infection or inflammation at the planned block site.
  • ASA physical status IV or higher.
  • Chronic opioid use or chronic pain requiring long-term analgesic therapy.
  • Advanced hepatic or renal insufficiency.
  • Severe pulmonary disease.
  • Opioid use within 24 hours before surgery.
  • Cognitive impairment or inability to complete postoperative assessments.
  • Revision breast surgery.
  • Refusal to participate in the study.

结局指标

主要结局

Postoperative pain intensity

时间窗: 24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)

Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.

次要结局

  • Intraoperative remifentanil consumption(During surgery)
  • Postoperative tramadol consumption(24 hours after surgery)
  • Postoperative nausea and vomiting(24 hours after surgery)
  • Quality of recovery(24 hours after surgery)
  • Rescue analgesic requirement(24 hours after surgery)
  • Block-related complications(From block performance until 24 hours after surgery)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

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