Randomized Controlled Trial of Nitrous Oxide Analgesia in External Cephalic Version (ECV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Mean Pain Score Experienced During Version
研究概览
简要总结
This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and pain associated with external cephalic version (ECV); a maneuver to turn the fetus from breech to cephalic position.
详细描述
Study Procedures:
Potential subjects will be identified as they are scheduled to undergo ECV at the UNC Department of Obstetrics and Gynecology. Subjects will be enrolled in the study by one of the study investigators. Details of the study will be reviewed with potential subjects and those wishing to enroll in the study will be consented for the study by one of the study investigators. Once enrolled participants will be randomized to receive either a mixture of 50% nitrous oxide in 50% oxygen or 100% oxygen, both of which will be delivered via the Nitronox apparatus. Demographic variables will be recorded for each participant at the time they are enrolled in the study
The Nitronox apparatus will be set up to deliver either 50% nitrous oxide in 50% oxygen or 100% oxygen by an anesthesia provider covering labor and delivery who is not involved in the study. The Nitronox device will be covered to prevent participants, study investigators and obstetricians performing the procedure from knowing whether nitrous oxide is being delivered. Nitrous oxide is odorless and colorless, so in that way is indistinguishable from oxygen.
Participants will be prepared for ECV according to current protocols for ECV at UNC. IV access will be obtained and tocolytic agents will be given according to current practice and protocols. Monitoring of maternal and fetal vital signs will be done according to current protocols.
Immediately before an ECV attempt participants will breathe through the facemask of the Nitronox device for 30 seconds and will then be free to use the device ad lib during the ECV attempt. Immediately following each attempt, while fetal monitoring is occurring, the participants will be asked to rate their maximum pain score during the previous attempt. They will also be asked to rate their current level of anxiety. This process will be repeated for any further ECV attempts.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Nitronox device will be covered. The person setting up the device with either 100% oxygen or 50% nitrous/50% oxygen, will not be participating in the study. The patient, investigator and labor and delivery personnel (obstetrician and nursing staff) will be blinded as to the medication being administered during the procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 18 years or greater
- •Scheduled to undergo external cephalic version due to singleton breech presentation
- •Not scheduled to have spinal or epidural anesthesia during the version procedure
- •American Society of Anesthesiology (ASA) Physical Status 1, 2 or
- •Able to provide informed consent and adhere to study protocol
排除标准
- •Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of exposure to nitrous oxide or complicate the subject's post-procedural course.
- •Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
研究组 & 干预措施
Nitrous Oxide
Patients will receive nitrous oxide during the version procedure.
干预措施: Nitrous Oxide (Drug)
Oxygen
Patients will receive placebo (100% oxygen) during the version procedure.
干预措施: Placebo (Other)
结局指标
主要结局
Mean Pain Score Experienced During Version
时间窗: During each version procedure, a total average of up to approximately 30 minutes
Pain scores will be collected following each version attempt using an 11 point scale (with 0 being no pain at all; 10 being worst pain imaginable), ranging from 0 to 10. Higher scores indicate more pain, lower scores indicate less pain. If more than one attempt, pain scores will be averaged to obtain a single score for the entire procedure.
次要结局
- Mean Anxiety Score Experienced During Version(During each version procedure, a total average of up to approximately 30 minutes)
- Mean Post-procedure Pain Score(Immediately Post-procedure, within approximately 15 minutes of final version attempt)
- Mean Post-procedure Patient Satisfaction Score(Immediately Post-procedure, within approximately 15 minutes of final version attempt)
- Mean Post-procedure Provider Assessed Level of Difficulty Score(Immediately Post-procedure, within approximately 15 minutes of final version attempt)