Abdominal Binder Study to Decrease Postoperative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edward R. Kost, M.D., Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01685593
First received: September 12, 2012
Last updated: September 13, 2012
Last verified: September 2012
  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 Blind (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 Brooke Army Medical Center:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    linear pain scale


Secondary Outcome Measures:
  • ambulations in 24 hours postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    number ambulations


Other Outcome Measures:
  • amount morphine used in 24 hours postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 12, 2012
Last Updated: September 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
abdominal binder

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014