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临床试验/NCT03427463
NCT03427463已完成早期 1 期

Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2018年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
229
试验地点
1
主要终点
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

研究概览

简要总结

The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

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
Single (Participant)

盲法说明

Patients will be blinded

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

  • any parturient 18 years of age or older
  • undergoing elective cesarean delivery under spinal anesthesia
  • able to consent to the study and participate in the follow-up.

排除标准

  • any known allergy to morphine
  • general anesthesia
  • urgent or emergent cases
  • any bleeding diathesis or other coagulopathy
  • known G6PD deficiency
  • any known liver disease
  • known alcohol abuse or dependence
  • HELLP syndrome
  • thrombocytopenia or known platelet dysfunction
  • history or active gastrointestinal bleeding
  • acute kidney injury or chronic renal insufficiency
  • contraindication/refusal to spinal anesthestic
  • chronic pain
  • chronic narcotic use
  • illicit drug use
  • allergy to any study related medications

研究组 & 干预措施

receiving 0.1 mg IT morphine

Active Comparator

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

干预措施: receiving 0.1 mg IT morphine (Drug)

recieving 0.05 mg IT morphine

Experimental

Patients will receive 0.05 mg of intrathecal morphine

干预措施: recieving 0.05 mg IT morphine (Drug)

结局指标

主要结局

Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

时间窗: 24 hours

This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.

次要结局

  • Time to First Ambulation After C-section(up to 48 hours)
  • Opioid Medication Given During the Participant's Hospital Stay.(From the time of the procedure through discharge, up to 48 hours.)
  • Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.(24-hours post operatively and 48-hours post operatively)
  • Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)(24 hours post operavtively)
  • Overall Patient Satisfaction With Pain Control(48 hours post-op)

研究者

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

Katherine Hatter, MD

Assistant Professor

Medical University of South Carolina

研究点 (1)

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