The Analgesic Efficacy of Perineural Nalbuphine as an Adjuvant to Bupivacaine in Ultrasound Guided Superficial Cervical Plexus Nerve Block for Thyroid Surgeries. A Double Blinded Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours.
研究概览
简要总结
This study aiming to evaluate the analgesic effect of adding nalbuphine as an adjuvant to bupivacaine in superficial cervical plexus block during thyroid surgeries regarding first rescue analgesia in the first twenty-four hours postoperative, VAS score after extubation and complications such as postoperative nausea, vomiting and respiratory depression.
详细描述
Thyroidectomy is a common and painful procedure demanding analgesia. Patients may experience discomfort in swallowing, burning sensation in the throat, nausea, and vomiting, which are all caused by the surgical procedures or general anaesthesia. Thyroid surgeries induce brief postoperative pain caused by several mechanisms. One of the mechinsims of this Post-operative pain, believed to be due to the interruption of the rich nerve supply present in the neck.
A lot of drugs have been used to decrease this postoperative pain such as non-steroidal anti inflammatory drugs , opioids or regional blocks. Traditionally, opioids have been the mainstay of postoperative analgesia, specifically at thyroid and parathyroid surgical centers, where narcotic analgesics make up the major component of their postoperative pain control regimens. However, the use of opioids has been linked to an increased risk of postoperative complications that include ventilatory depression, sedation, postoperative nausea and vomiting (PONV), pruritis, difficulty of voiding, ileus and surgical site infections which can in turn contribute to delayed hospital discharge. Further acute and chronic opioids can have significant effects on the endocrine system. Longer-term use of opioids may lead to dependence and substance abuse disorder.
The skin overlying the neck, ear, angle of the mandible, shoulder, and clavicle is supplied by the superficial cervical plexus (SCP), which is a sensory neural plexus formed from the ventral rami of the first four cervical nerves (C1-C4). It emerges behind the posterior border of sternomastoid muscle.
Bilateral superficial cervical plexus block (SCPB) has shown good intraoperative and postoperative analgesia in upper neck surgeries especially in thyroidectomies, this regional block can be facilitated by using ultrasound guided technique as it provides good visualisation of the anatomical structures and decreases the complications.
There has always been a search for ideal adjuvants in peripheral nerve blocks which prolong the duration of analgesia with lesser adverse effects, Recently, nalbuphine was studied frequently as an adjuvant to local anesthetics in spinal and epidural and the results of all studies concluded that nalbuphine is effective when used as an adjuvant to local anaesthetics in spinal and epidural as it significantly prolongs the block duration.
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, Investigator)
盲法说明
• Patients will be randomized using a computer-generated randomization list. Random group assigned will be enclosed in a sealed envelope to ensure concealment of allocation sequence. The sealed envelope will be opened by an anaesthesiologist who will not be involved in the study to prepare the drug solution according to randomization. The anaesthesiologist performing the block and observing the patient will be blinded to the treatment group.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 to 60 years old of both sexes undergoing elective thyroid surgery.
- •ASA I and II.
排除标准
- •Patient refusal.
- •Hypersensitivity or contraindication to nalbuphine or bupivacaine.
- •Pregnancy or lactating mothers.
- •Hepatic, cardiac or renal diseases.
- •Bleeding disorders.
- •Severe neurological or psychological disorders.
- •Goitres with retrosternal extension.
- •Any anatomical disruption in the neck (ex: metastatic lymph nodes).
研究组 & 干预措施
Group (C) control group
Patients will receive bilateral superficial cervical plexus block with 28 ml bupivacine 0.25% mixed with 2 ml saline 0.9%, to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia.
干预措施: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block (Drug)
Group (N) Perineural Nalbuphine
Patients will receive bilateral superficial cervical plexus block with 28 ml Bupivacaine 0.25% mixed with 10 mg nalbuphine in saline 0.9% to a volume of 30 ml, 15 ml on each side of the neck before induction of general anaesthesia.
干预措施: Adding perineural Nalbuphine to Bupivacaine in superficial cervical nerve block (Drug)
结局指标
主要结局
time to first rescue analgesia (will be given to VAS score > 4) following surgery in the first 24 hours.
时间窗: First 24 hours postoperative
defined as the time interval between the end of surgery and the first request to postoperative Nalbuphine
次要结局
- Intraoperative hemodynamics(every 10 minutes until the end of the surgery)
- VAS score after extubation(at 0,2,6,12,18 and 24 hours after completion of surgery.)
- Total amount of nalbuphine administrated to the patient 24 hours postoperative.(Every one hour postoperative for 24 hours)
研究者
Omnia Yahia El Sayed Kamel
Lecturer of anesthesiology and surgical ICU and pain management
Cairo University
