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Abdominal Binder Study to Decrease Postoperative Pain

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ClinicalTrials.gov Identifier: NCT01685593
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Postoperative Pain Device: abdominal binder Other: no binder

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.
Study Start Date : January 2001
Primary Completion Date : February 2006
Study Completion Date : February 2006
Arms and Interventions

Arm Intervention/treatment
Sham Comparator: regular bandage
no abdominal binder
Other: no binder
Experimental: abdominal binder
Device: abdominal binder

Outcome Measures

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 24 hours ]
    linear pain scale

Secondary Outcome Measures :
  1. ambulations in 24 hours postoperatively [ Time Frame: 24 hours ]
    number ambulations

Other Outcome Measures:
  1. amount morphine used in 24 hours postoperatively [ Time Frame: 24 hours ]
    mg morphine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • gynecologic abdominal laparotomy patients

Exclusion Criteria:

  • non gynecologic abdominal laparotomy patients
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685593

United States, Texas
Brooke Army Medical Center
Ft Sam Houston, Texas, United States, 78232
Sponsors and Collaborators
Brooke Army Medical Center
More Information

Responsible Party: Edward R. Kost, M.D., Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01685593     History of Changes
Other Study ID Numbers: C.2001.128
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by Edward R. Kost, M.D., Brooke Army Medical Center:
abdominal binder

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms