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Use of Cyclobenzaprine After Vaginal Surgery

Information source: NorthShore University HealthSystem Research Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: cyclobenzaprine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: NorthShore University HealthSystem Research Institute

Official(s) and/or principal investigator(s):
Kelly Jirschele, DO, Principal Investigator, Affiliation: NorthShore University HealthSystem

Summary

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 (FlexerilŽ) 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Faces Pain scale

Quantity of pain medications

Secondary outcome: Constipation scale

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Evanston NorthShore University HealthSystem, Evanston, Illinois 60201, United States; Recruiting
Manhan K Vu, DO, Phone: 847-570-2750
Manhan K Vu, DO, Principal Investigator
Additional Information

Starting date: April 2010
Last updated: July 23, 2013

Page last updated: August 20, 2015

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