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临床试验/NCT06869967
NCT06869967招募中不适用

Evaluation of Ultrasound-Guided Auricularis Magnus Nerve Block for Postoperative Pain Control in Ear Surgery

Kocaeli University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

详细描述

Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Ultrasound-guided auricularis magnus nerve block can be used as a potential solution to these problems. Ultrasound-guided peripheral nerve block can be visualized. It is appropriate and applicable to block a single distal nerve with a small dose of local anesthetic under ultrasound guidance. Ultrasound-guided blocking of the blocked area has reduced side effects with increased accuracy and accurate analgesic effect.

In middle ear microsurgery, the nerve innervation of the postauricular incision area may not primarily originate from the auricularis magnus. Therefore, clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

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

  • Patients undergoing CWD and Mastodectom
  • Patients undergoing elective surgery
  • ASA (American Society of Anesthesiologists) physical status classification I-II
  • Patients over 18 years of age

排除标准

  • Anticoagulant use
  • Allergy to the drugs to be used
  • ASA (American Society of Anesthesiologists) physical status classification IV-V
  • Presence of infection in the area where the block will be applied
  • Patient's refusal to accept the block application or inability to cooperate with the patient

研究组 & 干预措施

Control

Active Comparator

In the control group, patients will be administered intravenous analgesics of 1 gram paracetamol, 20 mg tenoxicam, and 8 mg ondansetron 30 minutes before the end of the operation, as stated in the patient protocol, during their follow-up after general anesthesia.

干预措施: Control Group (Procedure)

Auricularis Magnus Nerve Block

Active Comparator

Ultrasound (US) -guided Auricularis Magnus Nerve Block with 5 ml 0.5 % bupivacaine will performe preoperatively to all patients in the AMG group.

干预措施: Auricularis Magnus Nerve Block (Procedure)

结局指标

主要结局

Opioid consumption

时间窗: During the operation

Intraoperative opioid consumption

次要结局

  • Morphine consumption(1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4))
  • NRS Scores(1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nur Nazire Yucal

Doctor

Başakşehir Çam & Sakura City Hospital

研究点 (1)

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