Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
This study aims to compare the analgesic efficacy of the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine in patients undergoing cesarean section (CS).
详细描述
Cesarean section (CS) is a commonly performed major surgical procedure that results in substantial postoperative pain and patient dissatisfaction.
Spinal anesthesia is commonly used in CS surgery. However, it may be associated with several side effects, particularly hypotension.
Dexmedetomidine is an α2 adrenergic receptor agonist that has an analgesic effect.
Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 40 years.
- •American Society of Anesthesiology (ASA) physical status II.
- •Women undergoing cesarean section under spinal anesthesia.
排除标准
- •Contraindication to spinal anesthesia.
- •Women with body mass index >40 kg/m
- •Pregnancy-induced hypertension
- •Local infection at the site of injection.
- •Known cardiovascular disease
- •Coagulation abnormality.
- •History of chronic pain.
- •Abuse of drugs or alcohol.
- •History of allergies to any study medications.
- •Seizure disorders.
- •Any pregnancy complications requiring conversion to general anesthesia.
研究组 & 干预措施
TFP group
Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.
干预措施: Transversalis fascia plane block (Other)
Control group
Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) + (5 µg intrathecal dexmedetomidine diluted in 0.5ml saline) with a sham block at the end of surgery.
干预措施: Intrathecal dexmedetomidine (Drug)
结局指标
主要结局
Degree of pain
时间窗: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18 and 24 h postoperatively.
次要结局
- Total morphine consumption(24 hours postoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Mean arterial pressure(Till the end of surgery (Up to 2 hours))
- Heart rate(Till the end of surgery (Up to 2 hours))
- Incidence of adverse events(24 hours postoperatively)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University