The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Quantity of pain medications
研究概览
简要总结
The management of post-operative pain in patients after vaginal surgery provides many unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach for the repair of pelvic floor prolapse and urinary incontinence, patients may still experience varying degrees of discomfort and post-operative pain. Narcotics, however, can introduce a host of problems in addition to the potential addictive properties of the medication. A vicious cycle ensues as patients seek better pain control at the expense of worsening constipation, but without adequate control of pain after surgery, voiding dysfunctions are often exaggerated.
Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management of acute musculoskeletal injuries, but the practice of prescribing this centrally acting muscle relaxant for post-operative patients has also been successful in the management of pain.
An online search of medical databases revealed that there are currently no published retrospective or prospective studies determining the efficacy of cyclobenzaprine in post surgical patients in conjunction with traditional pain management. The investigators hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently, the reduction of narcotics and the control of post-surgical pain may also hasten the return of normal urinary and defecatory function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 18-70 years old
- •Undergoing vaginal surgery with apical or posterior repair requiring hospitalization
- •Willingness to participate in the study
- •Normal neurological exam
- •English speaking
排除标准
- •Contraindication to NSAIDs
- •Allergy to hydrocodone, hydromorphone, or cyclobenzaprine
- •Renal disease
- •Use of any antidepressants including SSRI, SNRI, MAOI in the last 3 months
- •Hyperthyroidism
- •Uncontrolled hypertension (>160/100 mm Hg)
- •History of chronic narcotic use in the last 3 months
- •History of pelvic pain
研究组 & 干预措施
Placebo Pill
干预措施: cyclobenzaprine (Drug)
Flexeril
干预措施: cyclobenzaprine (Drug)
结局指标
主要结局
Quantity of pain medications
时间窗: 2 weeks
Faces Pain scale
时间窗: 2 weeks
次要结局
- Constipation scale(2 weeks)
