Fentanyl and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Superficial Cervical Plexus Block in Thyroid Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain degree
研究概览
简要总结
This study aimed to compare the analgesic efficacy between fentanyl and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided superficial cervical plexus block for thyroid surgeries.
详细描述
Cervical plexus blocks are easy to perform and provide anesthesia for the surgical procedure in the distribution of C2 to C4, including carotid endarterectomies, lymph node dissection, and thyroid surgeries.
Dexmedetomidine (α2 adrenoceptor agonist) is being used for intravenous (IV) sedation and analgesia for intubated and mechanically ventilated patients in Intensive Care Units. Its use in peripheral nerve blocks has recently been described. It has been reported to have a rapid onset time,prolong the duration of local anesthetics, and it is approximately 8 times more potent than clonidine and is also reportedly safe and effective in peripheral nerve blocks.
Opiates are widely known to have an analgesic effect at the central and spinal cord level. However, opioid analgesia can be initiated by activation of peripheral opioid receptors. Opioids such as fentanyl have been used for regional nerve plexus blocks to improve the block duration and quality.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's approval.
- •Aged 20-65 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Undergoing thyroid surgery
- •Euthyroid patients
排除标准
- •Patient refusal.
- •Age: >65 and <20 years.
- •Allergy to Dexmedetomidine, local anesthetics, systemic opioids and any of the drugs included in the multimodal perioperative pain protocol.
- •Patient with coagulation disorders.
- •Chronic pain syndromes and patients with chronic opioid use are defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
- •BMI of 35 kg/m2 or more.
- •Physical Status: American Society of Anesthesiologists (ASA) III & IV.
- •Local infection or sepsis at the site of injection.
研究组 & 干预措施
Group C (Control)
Patients received superficial cervical plexus block with 1 ml of normal saline with 7ml bupivacaine 0.25% per side without adjuvants.
干预措施: Superficial cervical plexus block (Drug)
Group F (Fentanyl)
Patients received superficial cervical plexus block with fentanyl 1 ml (50 microgram) as an adjuvant to 7ml bupivacaine 0.25% per side.
干预措施: Superficial cervical plexus block + Fentanyl (Drug)
Group D (Dexmedetomidine)
Patients received superficial cervical plexus block with dexmedetomidine 0.5mcg/kg in 1 ml of normal saline as an adjuvant to 7ml bupivacaine 0.25% per side.
干预措施: Superficial cervical plexus block + Dexmedetomidine (Drug)
结局指标
主要结局
Pain degree
时间窗: 24 hours postoperatively
Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 indicates the worst imaginable pain. It was assessed at 0, 2, 4, 6, 8, 12, 18, and 24 hours post-surgery.
次要结局
- Duration of Sensory Block(24 hours postoperatively)
- Time to First Rescue Analgesia(48 hours postoperatively)
- Total Opioid Consumption(48 hours postoperatively)
- Mean arterial pressure (MAP)(24 hours postoperatively)
- Heart rate(24 hours postoperatively)
- Incidence of Adverse Events(48 hours postoperatively)
研究者
Adel Abd Elmoaty Basyouni Elabd
Resident at Anaesthesia, Surgical Intensive Care and Pain Management , Faculty of Medicine, Kafr Elsheikh University Kafr Elsheikh, Egypt.
Kafrelsheikh University