跳至主要内容
临床试验/NCT06968065
NCT06968065招募中不适用

Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)

İstanbul Yeni Yüzyıl Üniversitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.

研究概览

简要总结

This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.

详细描述

Minimally invasive cardiac surgery (MICS) has gained popularity due to reduced surgical trauma and faster recovery. However, postoperative pain management remains a challenge. This study evaluates the analgesic effectiveness of combining two interfascial plane blocks-SAP and SIP-under ultrasound guidance, compared to traditional local wound infiltration. A total of 60 patients scheduled for MICS with cardiopulmonary bypass will be randomized into two groups (SAP+SIP vs LWI). Pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-75 years
  • •Undergoing MICS with left-sided 4th-5th intercostal incision
  • •ASA I-III
  • •Informed consent provided

排除标准

  • •Coagulopathy or on anticoagulants
  • •Allergy to local anesthetics or opioids
  • •Local infection at block site
  • •Pregnancy or lactation
  • •Bilateral thoracic incisions
  • •Refusal to participate

研究组 & 干预措施

SAP + SIP Block Group

Experimental

Participants in this arm will receive a combination of ultrasound-guided serratus anterior plane (SAP) block and serratus-intercostal interfascial plane (SIP) block. The SAP block will be performed using 30 mL of 0.25% bupivacaine, and the SIP block will use 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia.

干预措施: Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine (Procedure)

Local Wound Infiltration Group

Active Comparator

Participants in this arm will receive local wound infiltration (LWI) consisting of 40 mL of 0.25% bupivacaine. The infiltration will be applied to the surgical and drain sites after surgery.

干预措施: Local wound infiltration with bupivacaine (Procedure)

结局指标

主要结局

o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.

时间窗: 48 hours

The cumulative perioperative and postoperative opioid consumption measured in micrograms of fentanyl and milligrams of tramadol administered during the first 48 hours after surgery.

次要结局

  • NRS pain scores (static and dynamic) at 0, 2, 4, 8, 16, 24, 48, and 72 hours postoperatively.(0 to 72 hours postoperatively.)

研究者

发起方
İstanbul Yeni Yüzyıl Üniversitesi
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验