Use of Cyclobenzaprine After Vaginal Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: cyclobenzaprine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Contraindication to NSAIDs Allergy to hydrocodone, hydromorphone, or cyclobenzaprine Renal disease Use of any antidepressants including SSRI, SNRI, MAOI in the last 3 months Glaucoma Diabetes Hyperthyroidism Uncontrolled hypertension (>160/100 mm Hg) History of chronic narcotic use in the last 3 months History of pelvic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Pill<br> | Drug: cyclobenzaprine<br>* Cyclobenzaprine 5 mg TID for 7 days<br>|
| Experimental: Flexeril<br> | Drug: cyclobenzaprine<br>* Cyclobenzaprine 5 mg TID for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faces Pain scale |  | 2 weeks | 
| Quantity of pain medications |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation scale |  | 2 weeks |