Prospective Randomized Controlled Clinical Trial: Superior Hypogastric Nerve Block for Pain Control After Uterine Artery Embolization: Effect of Addition of Steroids on Duration of Analgesia
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity Measure (mm)
研究概览
简要总结
The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.
详细描述
Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.
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)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 30 and 60 years
- •diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure
排除标准
- •Contraindications to UAE
- •SHNB is deemed unsafe for the patient
- •Allergies to local anesthetic or steroid agent
- •History of inflammatory bowel disease or ulcerative colitis
- •Uncorrectable abnormal coagulation profile
- •Diabetes mellitus
研究组 & 干预措施
Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
干预措施: Bupivacaine (Drug)
Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
干预措施: Iohexol contrast (Other)
Bupivacaine and Triamcinolone
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.
干预措施: Triamcinolone (Drug)
Bupivacaine and Triamcinolone
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.
干预措施: Bupivacaine (Drug)
Bupivacaine and Triamcinolone
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.
干预措施: Iohexol contrast (Other)
结局指标
主要结局
Change in Pain Intensity Measure (mm)
时间窗: Baseline, 240 hours
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".
次要结局
未报告次要终点
研究者
Jessica K. Stewart, MD
Principal Investigator
University of California, Los Angeles