Evaluation of Intrathecal Neostigmine as an Adjuvant to Bupivacaine in Ameliorating Post-Dural Puncture Headache in Elective Caesarian Section: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Incidence of post-dural puncture headache
研究概览
简要总结
Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has been investigated widely and found to be an effective adjuvant to bupivacaine for postoperative analgesia.
The objective of the current study is to investigate the possible prophylactic role of intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.
详细描述
Upon arrival to the operating room standard monitors will be applied and continued all over the operation, an 18G peripheral intravenous (IV) cannula will be inserted, and 15 ml/kg of Ringer lactate solution will be infused.
The intrathecal block will be performed via a midline approach into the L3-4 or L4-5 interspaces in a sitting position under strict aseptic condition using a 25-gauge spinal needle after administration of 3 ml of lidocaine 2% (60 mg) as a subcutaneous infiltration, a 2.5 ml of hyperbaric bupivacaine, 0.5 % (12.5 mg) in addition to the content of the prepared study syringe will be mixed and slowly injected.
After ensuring sufficient anesthesia level by loss of sensation to pinprick at the T4 level, the surgical procedure will start with continuous hemodynamic monitoring and recording.
At the end of the surgery, the parturient will be transferred to the postoperative anesthesia care unit (PACU).
Parturients will be transferred to the obstetrics ward after fulfilling the criteria of the modified Aldrete scoring system ≥9.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block.
排除标准
- •Body mass index more than or equal to 35 kg/m
- •Any contraindication to Intrathecal blocks such as local infection, bleeding disorders, or parturient refusal.
- •Allergy to neostigmine or other drugs will be used in the study.
- •Long-term opioid use.
- •A history of chronic pain, migraine, cluster headache.
- •Digestive problems with nausea and vomiting; cognitive dysfunction or memory disorders.
- •Significant renal, hepatic, and cardiovascular diseases.
- •History of urinary retention or bronchial asthma.
- •Inadequate or failed Intrathecal block.
- •Complicated pregnancy such as hypertensive disorders of the pregnancy, abnormal placenta, or uterine atony.
研究组 & 干预措施
The Intervention group (N)
0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
干预措施: Neostigmine Methylsulfate (Drug)
The control group (C)
one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.
干预措施: Dextrose 5%/Nacl 0.9% Inj (Drug)
结局指标
主要结局
Incidence of post-dural puncture headache
时间窗: Two times daily for five days after intrathecal block.
any headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character.usually associated with neck stiffness, nausea, photophobia, and subjective hearing symptoms
次要结局
未报告次要终点
研究者
Ahmed Ismail Elnaggar
Principal Investigator
Alexandria University