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Abdominal Binder Study to Decrease Postoperative Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685593
First Posted: September 14, 2012
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edward R. Kost, M.D., Brooke Army Medical Center
  Purpose
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 Intervention
Postoperative Pain Device: abdominal binder Other: no binder

Study Type: Interventional
Study Design: 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.

Further study details as provided by Edward R. Kost, M.D., Brooke Army Medical Center:

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


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


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


Enrollment: 76
Study Start Date: January 2001
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: regular bandage
no abdominal binder
Other: no binder
Experimental: abdominal binder
binder
Device: abdominal binder

  Eligibility

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
Criteria

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


Locations
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 Submitted: September 12, 2012
First Posted: September 14, 2012
Last Update Posted: September 17, 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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms