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临床试验/NCT05533229
NCT05533229已完成不适用

Fentanyl Versus Morphine in Spinal Anesthesia for Caesarian Section - Study on Perioperative Analgesia, Side Effects and Patient 's Satisfaction

Dr. Mihai Octavian Botea1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年4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
发起方
入组人数
160
试验地点
1
主要终点
assessing the degree of patient's of satisfaction

研究概览

简要总结

Intrathecal morphine and fentanyl are used for anesthesia and perioperative pain management in caesarian section. Despite the fact that spinal Fentanyl is better tolerated, might not be enough for postoperative pain control. Morphine offers an improved analgesia but might be not tolerated due to a higher incidence of side effects, especially nausea and vomiting.

This is a prospective, randomized, double-blind, parallel study including 80 parturients scheduled for elective CS. Spinal anesthesia is consisting in bupivacaine (7.5 - 10 mg in relation to height) and either fentanyl 25 mcg (F group) either morphine 100 mcg (m group). It will be assessed intraoperative and postoperative pain scores, the incidence of sides effects, patient's satisfaction and systemic opioids consumption.

详细描述

The patients were randomly allocated into one of the two groups M (morphine) or F (fentanyl) with a sample size calculation at 1:1 ratio, using the envelope technique.

Group F (fentanyl) was administered hyperbaric bupivacaine 0.5% along with a standard dose of 25 mcg fentanyl, while group M (morphine) received hyperbaric bupivacaine 0.5% with a standard dose of 100 mcg morphine. The dose of hyperbaric bupivacaine 0.5% to be injected, was based on the patient's height and here were used a range of doses between 7.5 mg and 11 mg.

The study required two anesthetists. The first anesthetist was "in charge" and performed the spinal anesthesia and he was blind to the solution used. The second anesthetist randomly assigned the patient, drew up the intrathecal solution and provided the anesthetic mixture. By this method, the first anesthetist was totally blinded to the opioid used. All drugs were from the same manufacturer.

During the pre-anesthetic visit, the patient received information about the aims of the study, the method of anesthesia, and details about the pain management and about the pain assessment with the numeric pain scale (NPS). Patient's demographics data were obtained: height, term weight and age. Also, full medical past and drugs history, previous allergies and other important medical data were documented.

Pre-operatively a venous access was obtained with an 18 G. cannula and 500 ml of Ringer lactate solution was infused prior to anesthesia. Participants were fasting and received pantoprazol 40 mg and metoclopramide 10 mg as pre-anesthetic medication. The spinal anesthesia was performed in an aseptic technique with the patient in a sitting position, in the L3 - L4 interspace, using a midline approach, with a Whitacre 27 G. needle and the anesthetic mixture manually injected at a rate of 1 ml.15s-1, with a barbotage effect. A previous skin local anesthetic infiltration was performed with 2 ml of 1% lidocaine. After the block, the patient was placed in a supine position with a roll wedge placed under the right hip to displace the uterus to the left until fetal extraction. Volemic supply was assured with warm Ringer lactate (10-20 ml.kg-1hr-1). All patients than had anti-embolic socks on lower limbs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I-II patients
  • no medical past history
  • not known allergies to the used medication
  • no history of chronic pain ar regular use of analgesics
  • no past history of anxiety or depression
  • body weight ≥ 50 kg
  • elective C section indication
  • single fetus

排除标准

  • conversion from a natural delivery with/without an epidural anesthesia started
  • pregnant women with psychiatric disorder;
  • history of drug addiction; diagnosis of acute or chronic fetal distress; contraindication of spinal anesthesia;
  • patient refusal;
  • preeclamptic patients, patients who developed allergic reaction after enrolling in the study;
  • refusal of the pain killers or other protocol medication prescribed;
  • the necessity of surgical reintervention in the next 72 h after C-section;
  • previous administration of opioids and/or other central nervous system depressants.

研究组 & 干预措施

Pregnant patients scheduled for C section

Spinal anesthesia

干预措施: Fentanyl (Drug)

Pregnant patients scheduled for C section

Spinal anesthesia

干预措施: Morphine (Drug)

结局指标

主要结局

assessing the degree of patient's of satisfaction

时间窗: 6 months

assessing the degree of satisfaction on a five point scale with the highest rate as being "completely satisfied", followed by "satisfied", "so so", "unsatisfied" and "completely usatisfied"

to assess the perioperative analgesia using Numeric Pain Scale

时间窗: 6 months

assessing pain scores (at surgical incision, end of surgery, at 4 h, 6 h, 12 h, 24 h, 48 h, 72 h - postoperative the pain scores were assessed at rest and on mobilization); AUE72h (sum pain intensity differences area over 72 hours) and SPID72h (time-weighted sum pain intensity differences over 72 hours); the pain scores according to the Numeric Pain Scale it will be rated between 0 and 10, meaning 0 - no pain and 10 - the worst pain imaginable

次要结局

  • to assess the incidence of other side effects related to intrathecal opioids(6 months)
  • to assess the incidence of and degree of pruritus as a side effect related to intrathecal opioids(6 months)

研究者

发起方
Dr. Mihai Octavian Botea
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Mihai Octavian Botea

MD, PhD, Assistant professor

University of Oradea

研究点 (1)

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