Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- To compare the time to the first rescue analgesics
研究概览
简要总结
The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block.
Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.
详细描述
Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone.
The primary outcome will be time to the first rescue analgesics.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology(ASA) physical status II
- •Able to read and understand the information sheet and to sign and date the consent form
- •Scheduled for elective CS planned with Spinal anesthesia
- •Gestational age > 37 weeks and < weeks assessed on the dating scale.
排除标准
- •Complicated pregnancy; defined as having preeclampsia or placenta accreta,increta and percreta
- •Opioid addiction or dependence
- •Contraindications to TAP block( Ski infection, abdominal wall muscle defects)
- •Allergy to any medications used in the study
- •Case converted to General Anesthesia
- •Cases who develop postoperative hemorrhage, amniotic fluid embolism
研究组 & 干预措施
Group F
The intrathecal additive Fentanyl with hyperbaric bupivacaine
干预措施: Fentanyl HCl (Drug)
Group FT
The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
干预措施: Fentanyl HCl (Drug)
Group FT
The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
Group T
Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
To compare the time to the first rescue analgesics
时间窗: Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours
The time from the arrival to Postoperative care Unit to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia
次要结局
- Percentage of participants with treatment related side effects like pruritus, nausea and vomiting.(Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours)
研究者
Bijay Rayamajhi
Anesthesia Resident
Nepal Mediciti Hospital