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临床试验/NCT07139522
NCT07139522招募中不适用

The Efficacy of Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Time to first analgesic requirement

研究概览

简要总结

This study aims to compare the efficacy of adding dexamethasone and magnesium sulfate as an adjuvant to bupivacaine in bilateral erector spinae block in postoperative pain control in patients undergoing caesarean section under spinal anesthesia.

详细描述

Caesarean section (CS) is the most common abdominal surgery among women worldwide. Inadequately treated postoperative pain can contribute significantly to morbidity of surgical patients, resulting in the delay of patients' recovery and ability to return to daily functional activities, increased incidence of chronic pain, and post-traumatic stress syndrome.

The ultrasound-guided erector spinae plane (ESP) block is a recently described interfascial paraspinal plane technique that was initially used by Forero et al. for providing thoracic analgesia when performed at the level of T5 transverse process. Since the pain experienced after caesarean delivery using a Pfannenstiel incision has both a somatic and visceral component.

Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics.

Dexamethasone is a potent glucocorticoid medication commonly used as an adjuvant to reduce postoperative pain. The mechanisms of perineurally administered dexamethasone are likely attributed to complex interactions, including direct inhibition of signal transmission in nociceptive C fibres, local vasoconstriction, and reduced local inflammation.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 35 years.
  • Full-term, singleton, pregnant women.
  • American Society of Anesthesiologists (ASA) physical status II.
  • Scheduled for elective cesarean delivery under spinal anesthesia.

排除标准

  • Refusal of the patient.
  • Emergency caesarean sections.
  • Patients having chronic diseases as asthma, cardiovascular disorders (Significant arrhythmias, Severe Valvular diseases, congenital heart diseases, ischemic heart disease, cardiomyopathy, deep venous thrombosis ,and pulmonary embolism)
  • Renal impairment (Creatinine level ≥ 2mg/dl, urea ≥ 25mg/dL), liver impairment [Alanine aminotransferase (ALT) < 45 U/L, Aspartate aminotransferase (AST) < 45 U/L].
  • Allergy to the drug enrolled in the study.
  • Body mass index (BMI) ≥ 35 kg/m
  • Hypertensive disorders of pregnancy.
  • Contraindication to spinal anesthesia, such as coagulopathy [platelet count <150.000, international normalized ratio (INR) > 1.2], or local infection.
  • Requirement for conversion to general anesthesia after spinal anesthesia will also be excluded.

研究组 & 干预措施

Control group

Active Comparator

Patients will receive 20 ml 0.25% isobaric bupivacaine.

干预措施: Bupivacaine (Drug)

Dexamethasone group

Experimental

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).

干预措施: Dexamethasone (Drug)

Magnesium group

Experimental

Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).

干预措施: Magnesium sulphate (Drug)

结局指标

主要结局

Time to first analgesic requirement

时间窗: 24 hours postoperatively

Time to first analgesic requirement in the following 24 hours after cesarean delivery. It is the time elapsed between performing the assigned intervention and first morphine requirement.

次要结局

  • Degree of pain(24 hours postoperatively)
  • Obstetric Quality of Recovery(24 hours postoperatively)
  • Total morphine consumption(24 hours postoperatively)
  • Time to independent movement(24 hours postoperatively)
  • Incidence of complications(24 hours postoperatively)

研究者

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

Esraa Esmaeel Sayed Farrag

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Cairo University

研究点 (1)

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