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临床试验/NCT06416891
NCT06416891尚未招募4 期

Effect of Adding Dexamethasone to Bupivacaine 0.25% in Superficial Cervical Plexus Block on Surgical Field Visibility During Tympanomastoid Surgery in Adults, A Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
56
试验地点
1
主要终点
Modena bleeding score

研究概览

简要总结

The aim of this study is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery.

详细描述

Tympanomastoid surgery is a commonly performed otological procedure performed to treat various middle ear pathologies, including chronic otitis media, cholesteatoma, and mastoiditis (1). One of the most significant complications associated with tympanomastoid surgery is bleeding, which can result in surgical difficulties, prolonged operative time, and increased morbidity (2).

Pain is also a major concern post-surgery and can lead to patient discomfort and dissatisfaction (3). Achieving optimal surgical field visibility is of paramount importance to ensure precise and safe surgical interventions. However, the presence of intraoperative bleeding and inadequate visualization can significantly impede the surgeon's ability to perform the procedure effectively, leading to potential complications and suboptimal outcomes (4).

Conventional methods for pain management during tympanomastoid surgery often involve general anesthesia or local infiltration of anesthetic agents around the surgical site. However, these techniques may not adequately address pain control and can be associated with unwanted systemic side effects (5).

To minimize bleeding and pain and improve surgical field visualization, anesthetic techniques such as induced hypotension have been used to achieve adequate homeostasis and surgical field visualization during surgery (4).

Induced hypotension involves reducing systemic blood pressure, thereby decreasing blood flow to the surgical site, minimizing the risk of bleeding, and improving the surgical field's visualization, leading to better surgical outcomes (5). However, induced hypotension can lead to cerebral hypoperfusion, organ damage, and other serious complications (6).

研究设计

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

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I & ASA II patients
  • Patients undergoing tympanomastoid surgery.
  • Age group: from 21 to 70 years old.
  • Duration of surgery less than 5 hours.

排除标准

  • Patient refusal.
  • Uncooperative patients.
  • Allergy to local anesthetics or dexamethasone.
  • Anatomical abnormalities include malformations, deformities, growths, or structural irregularities.
  • Infection at injection site.
  • Coagulopathy: PTT > 40 seconds, INR > 1.4, platelet count < 100x10⁹. or drug induced bleeding disorders

研究组 & 干预措施

Bupivacaine

Active Comparator

SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline).

干预措施: bupivacaine 0.25% (Drug)

Bupivacaine plus dexamethasone

Active Comparator

SCPB will be administered using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + dexamethasone 0.5 ml + 4.5 ml of normal saline).

干预措施: dexamethasone 2 mg in bupivacaine 0.25% (Drug)

结局指标

主要结局

Modena bleeding score

时间窗: up to 5 hours

Grading of surgical field visualization

次要结局

  • Analgesia duration(24 hours)
  • Postoperative pain(24 hours postoperatively)
  • Surgeon satisfaction(1 hour postoperatively)

研究者

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

Kareem Mohammed Assem Nawwar

Lecturer

Cairo University

研究点 (1)

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