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临床试验/NCT04689217
NCT04689217已完成不适用

Intrathecal Nalbuphine is a Comparable Safer Alternative to Fentanyl for Intraoperative Pain Management During Uterine Exteriorization in Cesarean Section. A Randomized Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
intraoperative pain control

研究概览

简要总结

In case of cesarean section (CS) delivery, spinal anesthesia is the best anesthetic choice. It is simple to perform with rapid onset of anesthesia and lower incidence of failed block. Spinal anesthesia avoids the risk of aspiration, the neonatal depressant effect that may occur with general anesthesia (GA), and provides postoperative analgesia, however, spinal anesthesia has a lesser control on the level of blockade, may give insufficient visceral pain block and may be associated with nausea and vomiting especially during peritoneal traction, closure and uterine manipulation, exteriorization and rotation. A previous study reported nausea and vomiting in up to 70.5% patients in the spinal group while the incidence of moderate to severe pain was more frequent in exteriorized uterus patients.

Increasing the dosage of intrathecal local anesthetic may contribute to a decrease in the occurrence of intraoperative visceral pain, but at the cost of the risk and adverse effects of greater blockade.A variety of adjuvants have been used to prevent these disadvantages. The commonly used adjuvants include opioids; α2 stimulants such as clonidine and dexmedetomidine; NMDA receptor antagonist such as ketamine; GABA receptor agonists such as midazolam.

The added intrathecal opioids as fentanyl and nalbuphine to local anesthetics give a sufficient intraoperative visceral analgesia when they were used in C.S., with less sympathetic block and hemodynamic effect, and reduces the need for intraoperative analgesics with prolongation of postoperative analgesia.

Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects. It was synthesized attempting to produce analgesia without the undesirable side effects of mu agonist. Also, its combination with mu agonist opioids was tried by many researchers to decrease the incidence and severity of the common mu agonist side effects (respiratory depression, undesirable sedation, pruritus, bradycardia, nausea, vomiting and urinary retention), plus it can antagonize spinal induced shivering. Meanwhile, the benefits of both kappa and mu analgesia can be obtained.

Few studies compared the effects of intrathecal nalbuphine (opioid agonist-antagonist) and fentanyl (opioid agonist) as adjuvants to bupivacaine in spinal blocked for CS with variable results. However, they didn't compare their ability to control the visceral pain aggravated by uterine exteriorization in cesarean section under spinal anesthesia. This study will try to answer the question is nalbuphine effective enough in such scenario to be used routinely as a safer alternative to fentanyl, which is the opioid in common practice added to bupivacaine?

Aim of the study:

To compare the ability of the used doses in the study of intrathecal nalbuphine and intrathecal fentanyl to control the visceral pain aggravated by uterine exteriorization in cesarean section under spinal anesthesia

Objectives:

  • To evaluate the visual analog scale (VAS) for visceral abdominal and shoulder pain every 5 minutes and the maximum score will be recorded for 30 minutes from the time of baby delivery.
  • To calculate the total fentanyl used for VAS ⩾ 4

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

入选标准

  • forty-two female patients
  • ASA physical status I or II,
  • age between 20 and 45 years,
  • weight between 60 and 100 kg
  • height between 160 and 180 cm

排除标准

  • ASA III or IV,
  • patient refusal,
  • hypotensive patients,
  • infection at the site of injection,
  • coagulopathy
  • weight <60 and > 100 kg,
  • anticoagulant medications,
  • pre-existing neurological disease.
  • uncooperative patients,
  • cardiac disorder
  • respiratory disorder
  • allergy to local anesthetics.

研究组 & 干预措施

Group F

Experimental

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml fentanyl (25 μg)

干预措施: intrathecal drug injection (Drug)

Group N

Experimental

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.8 mg nalbuphine hydrochloride

干预措施: intrathecal drug injection (Drug)

Group C

Placebo Comparator

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline

干预措施: intrathecal drug injection (Drug)

结局指标

主要结局

intraoperative pain control

时间窗: 30 minutes after baby delivery

- The visual analog scale (VAS) for visceral abdominal pain in all groups after uterine exteriorization.VAS from 0 to 10 with 0 equal no pain and 10 equal the severist pain ever

次要结局

未报告次要终点

研究者

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

Sherif Abdullah Mohamed

Lecturer of anesthesia

Cairo University

研究点 (1)

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