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临床试验/NCT01081990
NCT01081990已完成不适用

The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery

NorthShore University HealthSystem1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: cyclobenzaprine (Drug)

Flexeril

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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