NCT06719180招募中4 期
A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
MediSys Health Network1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Milligrams of Morphine Equivalent Used
研究概览
简要总结
The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
- •Presence of malignancy
排除标准
- •Conversion to laparotomy
- •Previous multiple abdominal and/or pelvic surgeries
- •Significant medical comorbidities or cardiac history
- •Poor initial Aldrete score4 (<10)
- •Significant pre-op pain medication use
- •Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)
研究组 & 干预措施
Vaginal Cuff Anesthesia
Experimental
干预措施: Bupivacain (Drug)
Vaginal Cuff Saline
Placebo Comparator
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
结局指标
主要结局
Milligrams of Morphine Equivalent Used
时间窗: From enrollment to end of treatment at 4 hours.
次要结局
- Counts of Non-Opioid Analgesics Used(From enrollment to end of treatment at 4 hours.)
- Patient Change in Pain Score (0-10)(From Baseline to end of treatment at 4 hours)
研究者
研究点 (1)
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