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 scaleQuantity 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
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