Use of Cyclobenzaprine After Vaginal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: cyclobenzaprine

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston NorthShore University HealthSystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Pill	Drug: cyclobenzaprine; Cyclobenzaprine 5 mg TID for 7 days
Experimental: Flexeril	Drug: cyclobenzaprine; Cyclobenzaprine 5 mg TID for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Faces Pain scale	2 weeks
Quantity of pain medications	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Constipation scale	2 weeks

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Kelly Jirschele, DO, Northshore University Healthsystem

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Muscle Relaxants, Central; Cyclobenzaprine
• Other Study ID Numbers: EH10-073