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临床试验/NCT06064214
NCT06064214招募中不适用

Effect of Bilateral Ultrasound-Guided Intermediate Cervical Plexus Block Combined With General Anesthesia on THE Stress Response in Patients Undergoing Anterior Cervical Spine Surgery. A Randomized Controlled Study

Cairo University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
2
主要终点
• The serum cortisol level 24 hours postoperatively

研究概览

简要总结

The aim of the present study is to investigate the effect of Bilateral Ultrasound-Guided intermediate cervical plexus Block combined with general anesthesia on the stress and inflammatory response in patients undergoing anterior cervical spine surgery (ACSS)

详细描述

Stress response is the name given to the hormonal and metabolic changes which follow injury or trauma. It may lead to changes in the nervous, endocrine and immune systems, and alterations in metabolic processes and functions. The stress response can shift from an adaptive and protective role to a pathogenic occurrence, especially when it is strong and chronic.

Stress hormones, the most prevalent of which is cortisol, have a circadian pattern in which they gradually climb after night sleep to reach a peak at early morning wake-up time, then gradually decline as the day progresses .

This pattern, however, can be disrupted by any stressful situation, such as severe pain from surgery, which has been linked to a progressive rise in cortisol levels both intraoperatively and in the early postoperative period.

Cytokines are group of low molecular weight proteins that modulate the systemic inflammatory response elicited by surgical intervention. Increased levels of proinflammatory cytokines, including interleukin-6 (IL-6) which is the main cytokine responsible for inducing the systemic changes, is an early features of acute injury. Interleukin-6 could be a good marker for research purposes that reflects and compares postoperative stress levels.

Spine surgeries are increasingly being performed as short-stay surgical procedures, and anterior cervical decompression and fusion is one such procedure .Postoperative incisional pain has been described as moderate in intensity, requiring opioid analgesics in most cases. Nonetheless, opioid-related side effects such as nausea, vomiting, and respiratory depression are undesirable in these patients who are at risk for airway problems due to surgical retraction or wound hematoma.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I & ASA II patients.(The American Society of Anesthesiologists)
  • Age group: from 18 to 65 years old.
  • Patients undergoing anterior cervical discectomy or fixation.
  • Genders eligible for study: both sexes

排除标准

  • • Patient refusal.
  • Patient Undergoing posterior fixation in addition to anterior.
  • An allergy to local anaesthetics.
  • Infection at block puncture site.
  • Bleeding disorders (Coagulopathy: PTT(partial thromboplastin time) > 40seconds, INR(international normalised ratio) > 1.2, platelet count < 120 x 103 / L.).
  • Emergency surgeries & patients in sepsis

结局指标

主要结局

• The serum cortisol level 24 hours postoperatively

时间窗: pre operative and after 24 hours of operation

All operations will be performed in the morning, taking into consideration circadian rhythm of hormone release. In both groups, venous blood samples to measure serum cortisol level will be collected before surgery as a baseline, then 24 hours post-operative

次要结局

  • • The serum interleukien-6 24 hours postoperatively(pre operative and after 24 hours of operation)

研究者

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

Ahmed raafat taha abd el aziz

principle investigator

Cairo University

研究点 (2)

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