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临床试验/NCT05814744
NCT05814744已完成不适用

Efficacy of Adding Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery: Randomized Controlled Study

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
first rescue analgesia

研究概览

简要总结

The cervical plexus block (CPB) is one such block used to provide effective anesthesia and analgesia for surgery in the head and neck region. The cervical fascia was first described as a very strong and resisting structure, consisting of two layers, superficial and deep. But more recently classified the cervical fascia as superficial/subcutaneous and deep. The deep cervical fascia is further divided into three layers: (a) the superficial layer, which was also called the investing fascia but is now referred to as the masticator fascia, submandibular fascia or sternocleidomastoid (SCM)-trapezius fascia, (b) the middle layer, which is suggested as to be named as strap muscle fascia or visceral fascia; and (c) the deep layer or the 'prevertebral fascia'. Intermediate cervical plexus block (CPB) has been found to be very effective in procedures of neck such as thyroid surgeries and carotid endarterectomy. The duration of analgesia following the nerve blocks is a matter of concern as most of the blocks last for only a few hours. Interestingly, resurgence of the use of α2-agonists in combination with local anesthetics has dramatically improved the duration of action of these blocks. Dexmedetomidine is a potent α2 agonist and is now emerging as an adjuvant to regional anesthesia and analgesia. Little evidence is available supporting the usefulness of dexmedetomidine in bilateral intermediate CPB. Therefore, the current study will be conducted to compare the duration and effectiveness of post-thyroidectomy analgesia of bilateral intermediate CPB using 20 ml bupivacaine 0.25% (Group A) or 20 ml of bupivacaine 0.25% with 1 μg/kg dexmedetomidine (Group B).

详细描述

  • Objectives: The aim of this study is to evaluate the effect of adding dexmedetomidine as adjuvant to bupivacaine in ultrasound guided Intermediate Cervical Plexus Block (CPB) for thyroidectomy surgery.

  • Study Design : Double-blind randomized controlled study where both patient and investigator don't know the drug.

  • Study Methodology:

  1. Population of study & disease Condition Adult patients at National Cancer Institute scheduled for thyroidectomy fulfilling the eligibility criteria.
  2. Interventions:

All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g., complete blood picture, coagulation profile, liver & kidney functions, ECG for patients above 40 years, pulmonary function test (PFT) and any other necessary investigations if required for high-risk patients.)} Preoperative assessment at night of surgery. The patients will be instructed how to report pain by means of visual analogue scale [VAS] during the preoperative assessment. Informed consent will be obtained.

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
Double (Participant, Investigator)

盲法说明

double blind

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Physical status American society Anesthesiologists ASA II and III.
  • Age ≥ 18 and ≤ 60 Years.
  • Patient undergoing thyroidectomy for cancer surgery.

排除标准

  • Patient refusal.
  • Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
  • History of psychological disorders.
  • Retro-sternal goiter and altered anatomical landmarks.
  • Localized infection at the site of block.
  • Coagulopathy with international normalized ratio (INR) ≥ 1.6: hereditary (e.g., hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g., impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).

研究组 & 干预措施

Group (A)

Sham Comparator

bupivacaine 0.25% only

干预措施: Thyroidectomy Surgery (Procedure)

Group (A)

Sham Comparator

bupivacaine 0.25% only

干预措施: bupivacaine 0.25% (Drug)

Group (A)

Sham Comparator

bupivacaine 0.25% only

干预措施: Ultrasound-guided intermediate Cervical Plexus Block Technique (Procedure)

Group (B)

Active Comparator

bupivacaine 0.25% and dexmedetomidine

干预措施: dexmedetomidine (Drug)

Group (B)

Active Comparator

bupivacaine 0.25% and dexmedetomidine

干预措施: bupivacaine 0.25% (Drug)

Group (B)

Active Comparator

bupivacaine 0.25% and dexmedetomidine

干预措施: Thyroidectomy Surgery (Procedure)

Group (B)

Active Comparator

bupivacaine 0.25% and dexmedetomidine

干预措施: Ultrasound-guided intermediate Cervical Plexus Block Technique (Procedure)

结局指标

主要结局

first rescue analgesia

时间窗: the first 24 hours of postoperative period

First time (minutes) opioids requested postoperative when pain score is \>3 .

次要结局

  • Total intraoperative fentanyl consumption.(throughout the duration of the surgery)
  • postoperative opioids consumption.(24 hours postoperative)
  • Any complications will be recorded.(throughout the duration of the surgery and 24 hours postoperative)
  • Post-operative pain scores.(immediately postoperative (0 hours ), 2, 4, 6, 12 and 24 hours postoperative)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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