Use of Cyclobenzaprine After Vaginal Surgery | RxWiki

Use of Cyclobenzaprine After Vaginal Surgery

Overview[ - collapse ][ - ]

Purpose	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	Postoperative Pain
Intervention	Drug: cyclobenzaprine
Phase	N/A
Sponsor	NorthShore University HealthSystem Research Institute
Responsible Party	NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier	NCT01081990
First Received	March 4, 2010
Last Updated	July 23, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	March 4, 2010
Last Updated Date	July 23, 2013
Start Date	April 2010
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Faces Pain scale [Time Frame: 2 weeks] [Designated as safety issue: No] Quantity of pain medications [Time Frame: 2 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Constipation scale [Time Frame: 2 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Use of Cyclobenzaprine After Vaginal Surgery
Official Title	The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Postoperative Pain
Intervention	Drug: cyclobenzaprine Cyclobenzaprine 5 mg TID for 7 days
Study Arm (s)	Placebo Comparator: Placebo Pill Experimental: Flexeril

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	60
Estimated Completion Date	December 2013
Estimated Primary Completion Date	October 2013
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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01081990
Other Study ID Numbers	EH10-073
Has Data Monitoring Committee	Yes
Information Provided By	NorthShore University HealthSystem Research Institute
Study Sponsor	NorthShore University HealthSystem Research Institute
Collaborators	Not Provided
Investigators	Principal Investigator: Kelly Jirschele, DO NorthShore University HealthSystem
Verification Date	July 2013

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