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临床试验/NCT07516717
NCT07516717已完成4 期

Efficacy and Safety of Two Doses of Intrathecal Morphine (75 mcg Versus 100mcg) for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Randomized, Double-blind Controlled Trial

Hospital Universitario de Caracas1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年1月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Postoperative pain intensity at 24 hours

研究概览

简要总结

This study evaluates the efficacy and safety of two different doses of intrathecal morphine (75 mcg versus 100 mcg) for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. Effective postoperative pain control is essential to improve maternal recovery, facilitate early mobilization, and enhance neonatal care. Participants were randomly of assigned to receive either 75 mcg or 100 mcg of intrathecal morphine dose that provides effective analgesia while minimizing adverse effects in the obstetric population.

详细描述

This prospective, randomized, double-blind controlled trial was designed to compare the analgesic efficacy and safety of two doses of intrathecal morphine (75 mcg versus 100 mcg) in patients undergoing elective cesarean delivery under spinal anesthesia. A total of 240 ASA physical status II patients schedule for elective cesarean delivery were enrolled and randomly assigned into two parallel groups. Patients received either 75 mcg or 100 mcg of intrathecal morphine as part of a standardized spinal anesthesia technique using local anesthetic. Randomization was performed using a predefined allocation method, and both patients and outcome assessors were blinded to group assignment. Perioperative management was standardized across both groups to minimize confounding variables. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at 2, 4, 8, 12 and 24 hours following surgery. The primary outcome was VAS pain score at 24 hours. Secondary outcomes included pain scores at earlier time points, requirement for rescue analgesia, incidence of opioid-related adverse effects (nausea, vomiting, pruritus), and neonatal outcomes assessed by Apgar scores. The objetive of this study was to determinethe optimal intrathecal morphine dose that provides effective postoperative analgesia while minimizing adverse effects in the obstetric population. The study was conducted in accordance with institutional ethical standards and approved by the corresponding ethics committee.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Participants and outcomeassessors were blinded to group allocation. Intrathecal morphine dose were prepared in identical syringes to ensure cincealment.

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

  • Pregnant women scheduled for elective cesarean delivery under spinal anesthesia.
  • Age between 18 and 45 years.
  • ASA physical status II
  • Singleton term pregnancy.
  • Ability to provide written informed consent.

排除标准

  • Contraindications to spinal anesthesia.
  • Known allergy or hypersensitivity to morphine or opioids.
  • Chronic opioid use or opioid dependence.
  • Significant systemic disease (ASA more or equal to III).
  • Pregnancy complications (e.g., preeclampsia, eclampsia).
  • Body mass index more than 40 kg/m
  • Infection at the puncture site.
  • Coagulopathy or anticoagulant therapy.
  • Refusal to participate.

研究组 & 干预措施

Intrathecal Morphine 75 mcg

Experimental

Participants receive a single intrathecal dose of 75 mcg morphine during spinal anesthesia for elective cesarean delivery.

干预措施: Intrathecal Morphine (Drug)

Intrathecal Morphine 100 mcg

Experimental

Participants receive a single intrathecal dose of 100 mcg morphine during spinal anesthesia for elective cesarean delivery.

干预措施: Intrathecal Morphine (Drug)

结局指标

主要结局

Postoperative pain intensity at 24 hours

时间窗: 24 hours after cesarean delivery

Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Measurements will be recorded at 2, 4, 8, 12 and 24 hours after surgery. The primary endpoint is the VAS score at 24 hours.

次要结局

  • Total opioid consumption within 24 horas(0 - 24 hours after surgery)
  • Incidence of postoperative nausea and vomiting (PONV)(0 - 24 hours after surgery.)
  • Incidence of pruritus(0 - 24 hours after surgery.)
  • Time to first rescue analgesia(0 - 24 hours after surgery.)
  • Neonatal outcome(at birth (1 and 5 minutes))

研究者

发起方
Hospital Universitario de Caracas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Alejandro Veraza Almeida

Chief of Operating Room And Anesthesiologist

Hospital Universitario de Caracas

研究点 (1)

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