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临床试验/NCT05781854
NCT05781854招募中2 期

Dexmedetomidine for Programed Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia: A Randomized Controlled Double-blind Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
total volume of local anesthetic

研究概览

简要总结

The aim of this study is to compare two modes of labour epidural analgesia:

programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour

详细描述

Labour although varies with the individual may be the most painful experience, any women may ever encounter. Concerns about pain in labour are as old as mankind. Pain can make patients feel uncomfortable and become sleepless and agitated. Pain also stimulates the sympathetic nervous system, which causes increase in the heart rate, blood pressure, sweat production, endocrine hyper-function, and delays the patients' prognosis. Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased. The ideal labor analgesia should be based on maternal and child safety and should have a fast-acting good analgesic effect and less adverse reaction. Different adjuvants such as opioids and α2-adrenergic agonists were added to local anesthetics to improve the quality of intraoperative and postoperative analgesia. Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia . Dexmedetomidine have several beneficial actions during perioperative period. It decreases the sympathetic tone with attenuation of the neuroendocrine and hemodynamic response to anesthesia and surgery, reduce anesthetic and opioid requirement, cause sedation and analgesia. Dexmedetomidine was used to enhance the analgesic property of local anesthetics like lidocaine, bupivacaine and ropivacaine. The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2-adrenergic agonist. Maintenance of epidural analgesia involved intermittent provider , administered boluses, patient-controlled epidural analgesia, and continuous epidural infusions with or without patient-controlled epidural analgesia. Continuous epidural infusion is the standard application setting for epidural infusion, highly effective, and provides consistent analgesia. however, is associated with greater local anesthetic consumption . A newer approach to maintenance of labor epidural analgesia involves the administration of programmed intermittent epidural boluses with patient-controlled epidural analgesia dosing for breakthrough pain. Earlier studies have suggested that programmed intermittent epidural boluses may be superior to continuous epidural infusion for labor analgesia and may be associated with a reduction in local anesthetic requirement, decreased motor blockade, lower risk of instrumental deliveries, and improved patient satisfaction. This may be related to increased pressure generated during automated boluses, resulting in improved distribution of the local anesthetic in the epidural space .

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 - 45 years
  • Scheduled for normal vaginal delivery
  • ASA physical status ӀI-IӀӀ.
  • Singleton non-complicated pregnancy.
  • At least 36 weak of gestation.
  • Vertex presentation.

排除标准

  • Patient refusal to epidural analgesia.
  • History of cardiac, liver, or kidney diseases.
  • History of allergy to amide local anesthetics or study medications.
  • Any neurological problem.
  • History of chronic opioid analgesic use.
  • Any contraindication of regional anesthesia.
  • Evidence of intrauterine growth restriction or fetal compromise.
  • Failed or unsatisfactory analgesic block.
  • Body mass index ≥40 kg/m2

研究组 & 干预措施

Group P (PIEB-group)

Active Comparator

After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

干预措施: Epidural analgesia with bupivacaine and dexmedetomidine (Drug)

Group C (CEI-group)

Active Comparator

After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

干预措施: Epidural analgesia with bupivacaine and dexmedetomidine (Drug)

结局指标

主要结局

total volume of local anesthetic

时间窗: 24 hour

total volume of local anesthetic received through patient controlled epidural analgesia per hour

次要结局

  • Blood Pressure(24 hour)
  • Likert scale for satisfaction(24 hour)
  • Bromage score for motor block(24 hour)
  • Ramsay sedation scale(24 hour)
  • Heart rate(24 hour)

研究者

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

Hassan Khaled ahmed gomaa

principal investigator , anesthesiology and ICU resident

Assiut University

研究点 (1)

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