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临床试验/NCT06355271
NCT06355271招募中不适用

Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial

Ente Ospedaliero Cantonale, Bellinzona1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
63
试验地点
1
主要终点
Patient Controlled Analgesia morphine consumption

研究概览

简要总结

Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery

详细描述

In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).

Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile

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

  • patients over 18 year of age
  • height over 160 cm
  • American Society Anesthesiologists physical status I and II
  • term singleton parturients
  • scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli

排除标准

  • patients with inability to consent
  • patient refusal
  • contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
  • emergency cesarean delivery
  • preeclampsia/eclampsia
  • allergy to drugs used in the protocol

研究组 & 干预措施

Control

Active Comparator

Spinal anesthesia with no fentanyl

干预措施: Fentanyl 1 (Procedure)

Experimental 1

Experimental

Spinal anesthesia with 10 mcg of fentanyl

干预措施: Fentanyl2 (Procedure)

Experimental 2

Experimental

Spinal anesthesia with 20 mcg of fentanyl

干预措施: Fentanyl 3 (Procedure)

结局指标

主要结局

Patient Controlled Analgesia morphine consumption

时间窗: Day 1 after cesarean section

Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours

obstetric quality of recovery score

时间窗: Day 1 after cesarean section

obstetric quality of recovery score (ObsQoR-11)

次要结局

  • Visual Analogue Scale(Day 1 after cesarean section)
  • satisfaction rate(Day 1 after cesarean section)
  • intraoperative pain(during the surgery)
  • pruritus(Day 1 after cesarean section (and day 0 for intraoperative pruritus))
  • intraoperative opioids(during the cesarean section)
  • nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity(Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting))
  • intraoperative hypotension(during the cesarean section)

研究者

发起方
Ente Ospedaliero Cantonale, Bellinzona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dossi Roberto

Dr. Med.

Ente Ospedaliero Cantonale, Bellinzona

研究点 (1)

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