Use of Cyclobenzaprine After Vaginal Surgery
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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 | Intervention |
|---|---|
|
Postoperative Pain |
Drug: cyclobenzaprine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery |
- 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 ]
- Constipation scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | December 2012 (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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders 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| 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 | |
| Principal Investigator: | Manhan K Vu, DO | NorthShore University HealthSystem |
More Information
No publications provided
| 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 |
| Study First Received: | March 4, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Cyclobenzaprine Amitriptyline Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Muscle Relaxants, Central |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Tranquilizing Agents Central Nervous System Depressants Analgesics, Non-Narcotic Analgesics Sensory System Agents Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013