Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time till home readiness
研究概览
简要总结
The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.
详细描述
Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.
Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.
Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.
Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Scheduled for perianal surgery under spinal anesthesia.
排除标准
- •Allergy to the studied drugs.
- •Patients with contraindications to spinal anesthesia.
- •Patients with advanced cardiac, renal, or hepatic diseases.
- •Previous voiding difficulty.
- •Patients taking anticholinergic medications.
- •Time of surgery exceeds 75 min.
研究组 & 干预措施
Hyperbaric prilocaine group
Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
干预措施: Hyperbaric prilocaine (Drug)
Hyperbaric bupivacaine group
Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.
干预措施: Hyperbaric bupivacaine (Drug)
结局指标
主要结局
Time till home readiness
时间窗: 24 hours postoperatively
The time-to-home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.
次要结局
- Time to block regression(6 hours postoperatively)
- Time of onset of motor block(Intraoperatively)
- Time to spontaneous voiding(24 hours postoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Total ketorolac consumption(24 hours postoperatively)
- Heart rate(Every 10 min till the end of surgery (up to 1 hour))
- Mean arterial pressure(Every 10 min till the end of surgery (up to 1 hour))
- 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