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Use of Cyclobenzaprine After Vaginal Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyclobenzaprine
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Evanston NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Pill

Flexeril

Arm Description

Outcomes

Primary Outcome Measures

Faces Pain scale
Quantity of pain medications

Secondary Outcome Measures

Constipation scale

Full Information

First Posted
March 4, 2010
Last Updated
September 9, 2019
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT01081990
Brief Title
Use of Cyclobenzaprine After Vaginal Surgery
Official Title
The Short-term Use of Cyclobenzaprine in Patients Undergoing Vaginal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Pill
Arm Type
Placebo Comparator
Arm Title
Flexeril
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cyclobenzaprine
Intervention Description
Cyclobenzaprine 5 mg TID for 7 days
Primary Outcome Measure Information:
Title
Faces Pain scale
Time Frame
2 weeks
Title
Quantity of pain medications
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Constipation scale
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Jirschele, DO
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evanston NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

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Use of Cyclobenzaprine After Vaginal Surgery

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