Use of Cyclobenzaprine After Vaginal Surgery

Postoperative Pain Clinical Trial

Official title:

The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081990
• Other study ID #: EH10-073
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: August 1, 2014

Study information

• Verified date: September 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 1, 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• cyclobenzaprine
Cyclobenzaprine 5 mg TID for 7 days

Locations

Country	Name	City	State
United States	Evanston NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faces Pain scale		2 weeks
Primary	Quantity of pain medications		2 weeks
Secondary	Constipation scale		2 weeks