A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
研究概览
简要总结
To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.
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
Subjects will not know if they received an injection of bupivacaine or placebo, i.e., normal saline after completion of surgery. The surgeon, as well as any investigator or study personnel, will be blinded to injection type.
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
- •Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.
排除标准
- •Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.
研究组 & 干预措施
Bupivacaine Arm
The subjects of this arm will receive an injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalad of the first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.
干预措施: Bupivacaine (Drug)
Placebo Arm
The subjects of this arm will receive an injection of 5mL of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalic from first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.
干预措施: normal saline 0.9% (Drug)
结局指标
主要结局
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
时间窗: 1 year
Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.
次要结局
- Postoperative care satisfaction scores, graded with a post-operative survey.(1 year)
- Measure of morphine equivalents used in patients postoperatively.(1 year)
- Length of hospital stay measured in hours.(1 year)
研究者
Carson T. Kaeser, MD
Fellow in Female Pelvic Medicine and Reconstructive Surgery
The Christ Hospital