The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Control / No Binder
Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
Abdominal binder
Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.
Intervention: Abdominal binder (Device)
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)
Investigators
Caitlin Carlton
Resident Physician, Primary Investigator
University Hospitals Cleveland Medical Center