Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
研究概览
简要总结
Background: Many thyroidectomy patients suffer from postoperative pain that could delay early hospital discharge and place a significant burden on both the patient and the healthcare team. Bilateral intermediate cervical plexus block (ICPB) provides good analgesia for neck surgery, including thyroidectomy. However, the duration of a single-shot nerve block is usually short. Therefore, adjuvants are used in peripheral nerve blocks.
Objectives: To compare the safety and efficacy of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided intermediate cervical plexus block in patients undergoing total thyroidectomy under general anesthesia.
Patients and Methods: This is a randomized, double-blind, phase four, prospective clinical trial; carried out on 60 patients, who were candidates for total thyroidectomy under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received bilateral ICPB with isobaric bupivacaine plus dexmedetomidine, and group B, received bilateral ICPB with isobaric bupivacaine plus dexamethasone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 60 years
- •Body Mass Index (BMI) ≤ 35 kg/m2
排除标准
- •ASA physical status > II
- •Age < 21 years or > 50 years
- •BMI > 35 kg/m2
- •Bronchial asthma
- •Chronic obstructive pulmonary disease
- •Restrictive lung diseases
- •Sick sinus syndrome
- •Sinus bradycardia
- •Hypertension
- •Chronic hypotension
- •Ischemic heart disease
- •Coagulopathies
- •Hepatic insufficiency
- •Renal insufficiency
- •Diabetes mellitus
- •Peripheral neuropathy
- •Thyroid malignancy
- •Hyperthyroidism
- •Substernal goiter
- •Patients on beta-blockers
- •Patients using pacemakers
- •Alcohol or drug abuse
- •Allergy to the study drugs
研究组 & 干预措施
Group A (n=30)
Dexmedetomidine group
干预措施: Dexmedetomidine Hydrochloride (Drug)
Group B (n=30)
Dexamethasone group
干预措施: Dexamethasone Phosphate (Drug)
结局指标
主要结局
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
时间窗: 24 hours after the end of the operation
NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At post anesthesia care unit (PACU), then every 2 hours till 24 hours)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
时间窗: 24 hours after the end of the operation
NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At PACU, then every 2 hours till 24 hours)
次要结局
- Number of participants and Percentage of Drug-related side effects(24 hours after the end of the operation)