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

Not Applicable

Terminated

• Conditions: Laparoscopic Surgery; Abdominal Surgery; Post Operative Pain; Pelvic Organ Prolapse

• Registration Number: NCT03684304
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Results First Submitted: 2022-03-06
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Results First Posted: 2022-05-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery	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 Outcome Measures

Name	Time	Method
To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.	1 day	Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.
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	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.

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States