Use of Cyclobenzaprine After Vaginal Surgery

NCT ID: NCT01081990

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-08-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Pill

Group Type: PLACEBO_COMPARATOR

cyclobenzaprine

Intervention Type: DRUG

Cyclobenzaprine 5 mg TID for 7 days

Flexeril

Group Type: EXPERIMENTAL

cyclobenzaprine

Intervention Type: DRUG

Cyclobenzaprine 5 mg TID for 7 days

Interventions

cyclobenzaprine

Cyclobenzaprine 5 mg TID for 7 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Jirschele, DO

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Evanston NorthShore University HealthSystem

Evanston, Illinois, United States

Countries

United States

Other Identifiers

EH10-073

Identifier Type: -

Identifier Source: org_study_id