VAS Correlation With BMI

December 16, 2013 updated by: Guniz M.Koksal, Istanbul University

Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial

The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery.

Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI >50

After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Marmara
      • Istanbul, Marmara, Turkey
        • Recruiting
        • Cerrahpasa Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.

Exclusion Criteria:

  • patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 5
Patients with BMI > 50
Drug: Morphine
Active Comparator: Group IV
Patients with BMI between 40 and 49.9
Drug: Morphine
Active Comparator: Group III
Patients with BMI between 35 and 39.9
Drug: Morphine
Active Comparator: Group II
patients with BMI between 30 and 34.9
Drug: Morphine
Active Comparator: Group I
Patients with BMI <30
Drug: Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: 48 hours
Correlation between the VAS Scores and BMI will evaluated
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 830458909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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