Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Thyroidectomy: a Prospective Randomized Controlled Study
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
- Morphine consumption
研究概览
简要总结
The aim of this study is to compare the analgesic efficacy of Dexmedetomidine and Ketamine as adjuvants to Bupivacaine in ultrasound-guided Bilateral SCPB in patients undergoing thyroidectomy
详细描述
Thyroid gland disorders are relatively widespread. These conditions encompass a range of issues, including hypothyroidism, hyperthyroidism, goiter, thyroid nodules, thyroiditis, and various forms of thyroid cancer. While some thyroid conditions can be effectively managed through medical treatment alone, surgical intervention - particularly thyroidectomy - continues to play a central role in addressing both benign and malignant thyroid diseases.
Despite being a relatively safe operation, various complications can occur including postoperative pain, which remains a significant concern affecting patient comfort, recovery, and overall satisfaction.
Poorly controlled postoperative pain may result in adverse events that may prolong the patient's hospital stay, delay patient recovery, and affect the patient's experience with the health care system.
The aim of this study is to compare the analgesic efficacy of Dexmedetomidine and Ketamine as adjuvants to Bupivacaine in ultrasound-guided Bilateral SCPB in patients undergoing thyroidectomy Adequate postoperative pain management is essential for enhancing functional recovery, promoting early mobilization, and facilitating timely discharge from the hospital.
Post thyroidectomy pain may be treated with medical treatment like acetaminophen , non steroidal anti inflammatory drugs or opioids. However, many surgeons are reluctant to use NSAIDs so soon after the procedure because of gastric upset and bleeding disorders , also can be treated by local infiltration or regional block.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 18 years
- •American Society of Anesthesiologists physical status I or II
- •scheduled for elective thyroid surgery will be included in the study.
排除标准
- •Patients who refuse to participate in the study.
- •Patients presented with mental and memory dysfunction.
- •Patients with history of allergy to local anesthetics.
- •Patients with history of chronic use of pain killers )most days for more than 3 months).
- •Patients presented with skin or soft tissue infection at the proposed site of needle.
- •Pre-existing major organ dysfunction such as hepatic or renal impairment.
研究组 & 干预措施
Group C (Control group)
Patients will only receive bilateral SCPB with 45mg bupivacaine diluted with normal saline (18 mL; 9 mL on each side) after intubation and before surgical incision.
干预措施: Group C (Control group) (Drug)
Group D (Dexmedetomidine group)
Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16mL and 1 μg/kg dexmedetomidine diluted with normal saline to 2mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.
干预措施: Group D (Dexmedetomidine group) (Drug)
Group K (Ketamine group)
Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16 mL and 1 mg/kg ketamine diluted with normal saline to 2 mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.
干预措施: Group K (Ketamine group) (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 24 hours
total 24 hours Morphine consumption(mg)
次要结局
- Assessment of post operative pain(immediately (T0),15 mins(T1),30 mins(T2),1 hour(T3),2 hours(T4),4 hours(T5)8 hours(T6),12 hours(T7),18 hours(T8),24 hours(T9) after arrival to recovery room)
研究者
Ahmed Abdulhamid Sroor Abdulhamid Eissa
Resident
Tanta University