Use of Cyclobenzaprine After Vaginal Surgery

NCT01081990 | Completed DMC

• 1 other identifier: EH10-073
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Faces Pain scale

  2 weeks

• Quantity of pain medications

  2 weeks

Secondary Outcomes (1)

• Constipation scale

  2 weeks

Study Arms (2)

Placebo Pill

PLACEBO COMPARATOR

Drug: cyclobenzaprine

Flexeril

EXPERIMENTAL

Drug: cyclobenzaprine

Interventions

cyclobenzaprine DRUG

Cyclobenzaprine 5 mg TID for 7 days

Flexeril; Placebo Pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Evanston NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kelly Jirschele, DO

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

US (1)