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Clinical Trials/NCT03684304
NCT03684304
Terminated
Not Applicable

The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery: A Randomized Controlled Trial

University Hospitals Cleveland Medical Center1 site in 1 country36 target enrollmentOctober 30, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
36
Locations
1
Primary Endpoint
To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.

Registry
clinicaltrials.gov
Start Date
October 30, 2017
End Date
March 22, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caitlin Carlton

Resident Physician, Primary Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients must be 18 years or older.
  • Willing and able to provide informed consent.
  • Patients must be undergoing scheduled pelvic surgery.
  • Patients must be admitted overnight (at least one night) after surgery.

Exclusion Criteria

  • Patients who are younger than 18 years old.
  • Patients who are unable or unwilling to provide informed consent.
  • Patients who are illiterate.
  • Patients who are non-English speaking or reading.
  • Patients who are unwilling to be contacted by phone after surgery.
  • Patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night.
  • Patients who are having surgery for any other indication other than pelvic surgery.
  • Patients with a chronic pain syndrome (as evidenced by daily intake of opioids).

Outcomes

Primary Outcomes

To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery

Time Frame: 7 days

Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents.

Secondary Outcomes

  • To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.(1 day)
  • To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder.(1 day)

Study Sites (1)

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