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Use of Cyclobenzaprine After Vaginal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Evanston Continence Center, NorthShore University HealthSystem Research Institute.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: March 5, 2010
Last Update Posted: July 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Evanston Continence Center, NorthShore University HealthSystem Research Institute

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.

Condition Intervention
Postoperative Pain Drug: cyclobenzaprine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery

Resource links provided by NLM:

Further study details as provided by Evanston Continence Center, NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Faces Pain scale [ Time Frame: 2 weeks ]
  • Quantity of pain medications [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Constipation scale [ Time Frame: 2 weeks ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Pill Drug: cyclobenzaprine
Cyclobenzaprine 5 mg TID for 7 days
Experimental: Flexeril Drug: cyclobenzaprine
Cyclobenzaprine 5 mg TID for 7 days


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081990

United States, Illinois
Evanston NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Manhan K Vu, DO    847-570-2750      
Principal Investigator: Manhan K Vu, DO         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Principal Investigator: Kelly Jirschele, DO NorthShore University HealthSystem
  More Information

Responsible Party: Evanston Continence Center, Northshore Urogynecology, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01081990     History of Changes
Other Study ID Numbers: EH10-073
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: July 24, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents