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VAS Correlation With BMI

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.
 
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

Tracking Information
First Submitted Date  ICMJE December 8, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date December 20, 2013
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Pain Scores on the Visual Analog Scale [ Time Frame: 48 hours ]
Correlation between the VAS Scores and BMI will evaluated
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VAS Correlation With BMI
Official Title  ICMJE Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Drug: Morphine
Study Arms  ICMJE
  • Active Comparator: Group 5
    Patients with BMI > 50
    Intervention: Drug: Morphine
  • Active Comparator: Group IV
    Patients with BMI between 40 and 49.9
    Intervention: Drug: Morphine
  • Active Comparator: Group III
    Patients with BMI between 35 and 39.9
    Intervention: Drug: Morphine
  • Active Comparator: Group II
    patients with BMI between 30 and 34.9
    Intervention: Drug: Morphine
  • Active Comparator: Group I
    Patients with BMI <30
    Intervention: Drug: Morphine
Publications * Choi YK, Brolin RE, Wagner BK, Chou S, Etesham S, Pollak P. Efficacy and safety of patient-controlled analgesia for morbidly obese patients following gastric bypass surgery. Obes Surg. 2000 Apr;10(2):154-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02017314
Other Study ID Numbers  ICMJE 830458909
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guniz M.Koksal, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istanbul University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP