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临床试验/NCT06621836
NCT06621836已完成4 期

Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations

Cairo University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年1月1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
已完成
入组人数
51
试验地点
1
主要终点
The duration of analgesia

研究概览

简要总结

Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during various head and neck procedures. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. Authors used 10 ml bupivacaine 0.25% bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on the diaphragmatic motion. [5] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy). We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on the diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.

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)

入排标准

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

入选标准

  • ASA physical status I-III,
  • scheduled for total thyroidectomy or total laryngectomy

排除标准

  • Heart failure,
  • A history of arrhythmias or treatment with antiarrhythmic drugs,
  • Impaired pulmonary, liver or kidney functions,
  • Neck infection or rash

研究组 & 干预措施

Group-H

Active Comparator

干预措施: ICPB H (Drug)

Group-L

Active Comparator

干预措施: ICPB - L (Drug)

结局指标

主要结局

The duration of analgesia

时间窗: Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours

次要结局

未报告次要终点

研究者

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

Abeer Ahmed, MD

Professor

Cairo University

研究点 (1)

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