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临床试验/NCT07432256
NCT07432256已完成不适用

The Effect of Adding a Parasternal Intercostal Plane Block to a Serratus Anterior Plane Block on Postoperative Opioid Consumption in Breast Reduction Surgery

Zonguldak Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月1日最近更新:
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
90
试验地点
1
主要终点
Total postoperative opioid consumption in the first 24 hours

研究概览

简要总结

This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery.

All patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption.

The study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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 18-65 years
  • Scheduled for elective breast reduction surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand the study and provide written informed consent

排除标准

  • Patient refusal
  • Known allergy to local anesthetics
  • Coagulopathy or ongoing anticoagulant therapy
  • Infection at the block site
  • Chronic opioid use or opioid dependence
  • Severe hepatic or renal insufficiency
  • Pregnancy or breastfeeding

研究组 & 干预措施

control

No Intervention

patients receive standard general anesthesia

Serratus Anterior Plane Block

Active Comparator

patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery

干预措施: Serratus Anterior Plane Block (SAPB) (Procedure)

Serratus Anterior Plane Block + Parasternal Intercostal Plane Block

Active Comparator

patients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery

干预措施: Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block (Procedure)

结局指标

主要结局

Total postoperative opioid consumption in the first 24 hours

时间窗: First 24 hours after surgery

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

次要结局

  • Quality of recovery by using QoR-15 questionnaire(postoperative 24th hour)
  • Pain Scores(postoperative 0, 1, 2, 6, 12, 24 th hour)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

emine bayraktar

MD

Zonguldak Bulent Ecevit University

研究点 (1)

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