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Completed

NCT Number: NCT01081990

Use of Cyclobenzaprine After Vaginal Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Evanston NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclobenzaprine

Drug

Cyclobenzaprine 5 mg TID for 7 days

Primary outcomes

  1. Faces Pain scale

    Time frame: 2 weeks

  2. Quantity of pain medications

    Time frame: 2 weeks

Secondary outcomes

  1. Constipation scale

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2010
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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