Clinical trial NCT01081990: Use of Cyclobenzaprine After Vaginal Surgery
Official title: The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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.


Eligibility 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

Primary outcomes:
measure: Faces Pain scale
timeFrame: 2 weeks
measure: Quantity of pain medications
timeFrame: 2 weeks
Secondary outcomes:
measure: Constipation scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Kelly Jirschele, DO
role: PRINCIPAL_INVESTIGATOR
References: