Pelvic Organ Prolapse, Abdominal Surgery, Laparoscopic Surgery, Post Operative Pain
Conditions
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.
Interventions
DEVICEAbdominal binder
The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control / No Binder Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course. | 19 |
| 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.
Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed. | 17 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 17 |
Baseline characteristics
| Characteristic | Control / No Binder | Total | Abdominal Binder |
|---|---|---|---|
| Age, Continuous | 51 years | 51 years | 51 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 36 Participants | 17 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 19 participants | 36 participants | 17 participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 7 days
Population: Data not collected
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.
Time frame: 1 day
Population: Data not collected
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.
Time frame: 1 day
Population: Data not collected