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Use of Cyclobenzaprine After Vaginal Surgery

N

NorthShore University HealthSystem

Status

Completed

Conditions

Postoperative Pain

Treatments

Drug: cyclobenzaprine

Study type

Interventional

Funder types

Other

Identifiers

NCT01081990
EH10-073

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

63 participants in 2 patient groups, including a placebo group

Placebo Pill
Placebo Comparator group
Treatment:
Drug: cyclobenzaprine
Flexeril
Experimental group
Treatment:
Drug: cyclobenzaprine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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