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VAS Correlation With BMI

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ClinicalTrials.gov Identifier: NCT02017314
Recruitment Status : Unknown
Verified December 2013 by Guniz M.Koksal, Istanbul University.
Recruitment status was:  Recruiting
First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Guniz M.Koksal, Istanbul University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
Study Start Date : November 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

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



Primary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 48 hours ]
    Correlation between the VAS Scores and BMI will evaluated



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02017314


Contacts
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Contact: guniz koksal, Ass.Prof 2124143000 ext 21876 gunizkoksal@hotmail.com

Locations
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Turkey
Cerrahpasa Medical School Recruiting
Istanbul, Marmara, Turkey
Contact: emre erbabacan, specialist    00905322067777    emreerbabacan@hotmail.com   
Sponsors and Collaborators
Istanbul University

Publications:
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Responsible Party: Guniz M.Koksal, Assc.Prof, Istanbul University
ClinicalTrials.gov Identifier: NCT02017314    
Other Study ID Numbers: 830458909
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013
Keywords provided by Guniz M.Koksal, Istanbul University:
morbid obesity
postoperative pain
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents