Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The time of the first postoperative analgesic requirement
研究概览
简要总结
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties
详细描述
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia
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, Investigator)
盲法说明
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 19 to 40 years old
- •American Society of Anesthesiologists (ASA) physical status II patients
- •Singleton pregnancies with a gestational age of at least 37 weeks.
- •Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
排除标准
- •Age < 19 or > 40 years.
- •Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m
- •Inability to comprehend or participate in the pain scoring system.
- •Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- •Hypersensitivity to any drug used in the study.
- •Any hypertensive disorders of pregnancy.
- •Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
- •Significant cardiovascular, renal or hepatic abnormalities.
- •Patients with history of opioid intake, drug abusers or psychiatric patients
研究组 & 干预措施
Group-Dexmedetomidine 0.5
After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side
干预措施: Dexmedetomidine 0.5 mcg (Drug)
Group-Dexmedetomidine1
After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side
干预措施: Dexmedetomidine 1 mcg (Drug)
结局指标
主要结局
The time of the first postoperative analgesic requirement
时间窗: during the first 24 postoperative hours
次要结局
- heart rate (HR)(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
- The level of sedation(during the first 24 postoperative hours)
- Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the(during the first 24 postoperative hours)
- The visual analog scale (VAS) scores during rest(during the first 24 postoperative hours)
- Mean arterial blood pressure (MBP)(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
- Patient satisfaction about the quality of postoperative analgesia(during the first 24 postoperative hours)
- The side effects (nausea, vomiting, abdominal colic and lower limb weakness)(during the first 24 postoperative hours)
- the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome(during the first 24 postoperative hours)
- The visual analog scale (VAS) scores during movement(during the first 24 postoperative hours)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University