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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03684304
• Other study ID #: binder071718
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: March 22, 2021

Study information

• Verified date: April 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Surgery
• Laparoscopic Surgery
• Pain, Postoperative
• Pelvic Organ Prolapse
• Post Operative Pain
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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