search
Back to results

Abdominal Binder Study to Decrease Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
abdominal binder
no binder
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring abdominal binder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • gynecologic abdominal laparotomy patients

Exclusion Criteria:

  • non gynecologic abdominal laparotomy patients

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

regular bandage

abdominal binder

Arm Description

no abdominal binder

binder

Outcomes

Primary Outcome Measures

postoperative pain
linear pain scale

Secondary Outcome Measures

ambulations in 24 hours postoperatively
number ambulations

Full Information

First Posted
September 12, 2012
Last Updated
September 13, 2012
Sponsor
Brooke Army Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01685593
Brief Title
Abdominal Binder Study to Decrease Postoperative Pain
Official Title
A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
abdominal binder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
regular bandage
Arm Type
Sham Comparator
Arm Description
no abdominal binder
Arm Title
abdominal binder
Arm Type
Experimental
Arm Description
binder
Intervention Type
Device
Intervention Name(s)
abdominal binder
Intervention Type
Other
Intervention Name(s)
no binder
Primary Outcome Measure Information:
Title
postoperative pain
Description
linear pain scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
ambulations in 24 hours postoperatively
Description
number ambulations
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
amount morphine used in 24 hours postoperatively
Description
mg morphine
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gynecologic abdominal laparotomy patients Exclusion Criteria: non gynecologic abdominal laparotomy patients
Facility Information:
Facility Name
Brooke Army Medical Center
City
Ft Sam Houston
State/Province
Texas
ZIP/Postal Code
78232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Abdominal Binder Study to Decrease Postoperative Pain

We'll reach out to this number within 24 hrs