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临床试验/NCT07661758
NCT07661758招募中3 期

Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2026年7月1日最近更新:
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
680
试验地点
1

研究概览

简要总结

This prospective randomized controlled multicenter study will be conducted to evaluate the effects of pre-emptive IV lidocaine dose on the incidence and severity of intraoperative headache that may occur after the extra-abdominal manual uterine fundal pressure in patients undergoing cesarean section under spinal anesthesia.

详细描述

This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience.

The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP).

Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels.

The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.

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)

盲法说明

Quadruple

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged ≥ 18 years
  • American Society of Anesthesiologists (ASA) Physical Status II
  • Scheduled for elective cesarean section under spinal anesthesia

排除标准

  • Patients declined to participate in the trial,
  • Patients with history of any type of headache, mental illness, or cerebrovascular diseases
  • Previous epidural insertion for painless labor or any other indications;
  • Patients on opioid or analgesic medications;
  • Those with pregnancy-induced hypertension or diabetic patients,
  • Allergy to lidocaine;
  • Contraindication or failure of spinal anesthesia.

研究组 & 干预措施

Control group

Placebo Comparator

IV 10 ml isotonic saline over the same period

干预措施: Saline 0.9% (Other)

Lidocaine group

Experimental

IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision

干预措施: Lidocaine IV (Drug)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Rehab

lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Tanta University

研究点 (1)

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