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NCT01081990 · ClinicalTrials.gov registry record · NA

Use of Cyclobenzaprine After Vaginal Surgery

A NA study, sponsored by Endeavor Health.

Completed
Registry status
NA
Development phase
63
Enrollment target

NCT01081990 is a NA study that has completed, run by Endeavor Health. The registered enrollment target is 63 participants.

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The verdict

NCT01081990, a NA study, has completed, sponsored by Endeavor Health.

COMPLETED
Registry status
NA
Development phase
63 participants
Enrollment target

Study 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.

Interventions

  • DRUG cyclobenzaprine

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2010-04
Est. Completion 2014-08-01
Phase NA

Sponsor

Endeavor Health

94 total trials

What the Registry Record Tells You About NCT01081990

The ClinicalTrials.gov registry entry for NCT01081990 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which cyclobenzaprine is the first listed.

NCT01081990 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01081990 about?

NCT01081990 is a clinical study titled "Use of Cyclobenzaprine After 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 discomf...

What is the current status of trial NCT01081990?

This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2010-04. Estimated completion is 2014-08-01.

What interventions are being tested in trial NCT01081990?

The interventions under investigation include: cyclobenzaprine (DRUG).

Who is sponsoring clinical trial NCT01081990?

This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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