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Use of Cyclobenzaprine After Vaginal Surgery

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ClinicalTrials.gov Identifier: NCT01081990
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
NorthShore University HealthSystem

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: cyclobenzaprine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 1, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Pill Drug: cyclobenzaprine
Cyclobenzaprine 5 mg TID for 7 days
Experimental: Flexeril Drug: cyclobenzaprine
Cyclobenzaprine 5 mg TID for 7 days


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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


Locations
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United States, Illinois
Evanston NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Kelly Jirschele, DO NorthShore University HealthSystem
More Information
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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01081990    
Other Study ID Numbers: EH10-073
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Cyclobenzaprine
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