NCT04198714已完成不适用
The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Visual Analog Scores at 7am After Surgery
研究概览
简要总结
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery
- •Ability to read VAS Scores
- •Specific vaginal procedures include, but are not limited to:
- •Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele
排除标准
- •History of chronic pelvic pain
- •Currently taking sedatives
- •Liver disease
- •Renal disease
- •Women who did not consent for the study.
- •Intraoperative concern for increased blood loss
- •Unable to speak English
- •Unable to understand VAS Scores
- •Undergoing concomitant abdominal or laparoscopic procedures
- •Allergy to bupivacaine or triamcinolone
- •Planned abdominal or laparoscopic procedures.
- •Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs
结局指标
主要结局
Visual Analog Scores at 7am After Surgery
时间窗: Postoperative day 1 at 7am
Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
次要结局
- Opioid Analgesic Use in the Post-anesthesia Care Unit(Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.)
- Visual Analog Scores at Discharge From Post-anesthesia Care Unit(At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery)
- Pain Scores 96 Hours After Surgery(96 hours postoperatively)
- Quality of Recovery Scores on Post op Day 1 (7AM)(7am on postoperative day 1)
- Satisfaction Scores in the Morning After Surgery (7AM)(7am on postoperative day 1)
- Total Postoperative Opioid Use(From the time a patient arrived in the post-anesthesia recovery unit until discharged from the hospital up to 24 hours OR time of their POD#1 phone call if discharged on same day as surgery up to 24 hours)
- Satisfaction Scores 96 Hours After Surgery(96 hours postoperatively)
- Severity of Postoperative Non-pain Symptoms(Postoperative day 1 (7AM))
- Number of Participants With Postoperative Urinary Retention(Up to 96 hours after surgery)
研究者
研究点 (2)
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