The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery

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

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 Overview

• Status: Terminated
• Conditions: Laparoscopic Surgery; Pelvic Organ Prolapse; Abdominal Surgery; Post Operative Pain
• Intervention / Treatment: Device: Abdominal binder

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control / No Binder; Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
Experimental: 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.	Device: Abdominal binder; The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.	Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.	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.	Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients.	1 day

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: binder071718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes