The Effect of Glass Particle Contamination From Bupivacaine Ampules on Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- The incidence of post-dural puncture headache (PDPH)
研究概览
简要总结
Post-dural puncture headache (PDPH) is a potential and debilitating complication of spinal anesthesia in pregnant patients undergoing caesarean sections (CS), with a reported incidence of 0.5%-2% .
详细描述
Various methods for the management of PDPH are present including proper hydration, maintaining a supine posture, caffeine, paracetamol, nonsteroid anti-inflammatory drugs (NSAID), theophylline, opioids like morphine and fentanyl, with the only clearly effective treatment being the epidural blood patch.
Glass particle contamination is known to occur on opening single-dose drug ampoules. Although supporting data are lacking, intrathecal drug administration during subarachnoid blocks and chemotherapy with glass particle contamination is potentially hazardous,
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturient with American Society of Anesthesiologists (ASA) class I or II
- •Age: 20-45 years old
- •A full-term pregnant female undergoing elective cesarean section under spinal anesthesia
排除标准
- •Contraindications to regional anesthesia (coagulopathy, infection at the needle insertion site)
- •History of Migraines or persistent headache
- •Known hypersensitivity to local anesthetics
- •Body mass index (BMI > 35 kg/m2)
- •Hypertensive disorders of pregnancy
- •Emergency cesarean section
- •Cardiorespiratory, hepatic, or renal impairment
- •History of a cerebrovascular accident, neurologic or psychological disorders
- •Uncontrolled hypertension
- •Spinal column surgery, chronic opioid consumption
- •Patients with more than one single attempt and patients with blood loss over 1000 mL who will need additional fluid supplementation or blood transfusion
- •Patient refusal
研究组 & 干预措施
Group T0
Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) immediately after opening the bupivacaine ampule and directly after immediate aspiration with an unfiltered 3 ml syringe
干预措施: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule (Drug)
Group T5
Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) directly after 5 min' delayed aspiration from opening of the bupivacaine ampule with an unfiltered 3 ml syringe to allow glass particles to settle onto the bottom of the ampule
干预措施: Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule (Drug)
结局指标
主要结局
The incidence of post-dural puncture headache (PDPH)
时间窗: The first 120 hours during the post-partum period.
Assessed using the visual analog score of pain which ranges from 0-10, where 0 = no pain and 10 = maximum worst pain
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Princible investigator
Assiut University