Effect of Addition of Steroids on Duration of Analgesia
关键词
抽象
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.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 10/06/2019 |
| 提交的预估入学人数: | 10/13/2019 |
| 首次发布: | 10/14/2019 |
| 上次提交的更新: | 06/23/2020 |
| 最近更新发布: | 06/25/2020 |
| 实际学习开始日期: | 11/04/2019 |
| 预计主要完成日期: | 09/30/2020 |
| 预计完成日期: | 09/30/2021 |
状况或疾病
干预/治疗
Drug: Bupivacaine and Triamcinolone
Drug: Bupivacaine
Other: Iohexol contrast
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 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. | |
| Experimental: 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. | Drug: Bupivacaine and Triamcinolone 40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB) |
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - females - aged between 30 and 60 years - diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure Exclusion Criteria: - 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 |
结果
主要结果指标
1. Change in Pain Intensity Measure (mm) [Baseline, 240 hours]
