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VAS Correlation With BMI

Primary Purpose

Morbid Obesity

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Morphine

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cerrahpasa Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

Group 5

Group IV

Group III

Group II

Group I

Arm Description

Patients with BMI > 50

Patients with BMI between 40 and 49.9

Patients with BMI between 35 and 39.9

patients with BMI between 30 and 34.9

Patients with BMI <30

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analog Scale

Correlation between the VAS Scores and BMI will evaluated

Secondary Outcome Measures

Full Information

NCT ID

NCT02017314

First Posted

December 8, 2013

Last Updated

December 16, 2013

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT02017314

Brief Title

VAS Correlation With BMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

Keywords

morbid obesity, postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 5

Arm Type

Active Comparator

Arm Description

Patients with BMI > 50

Arm Title

Group IV

Arm Type

Active Comparator

Arm Description

Patients with BMI between 40 and 49.9

Arm Title

Group III

Arm Type

Active Comparator

Arm Description

Patients with BMI between 35 and 39.9

Arm Title

Group II

Arm Type

Active Comparator

Arm Description

patients with BMI between 30 and 34.9

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

Patients with BMI <30

Intervention Type

Drug

Intervention Name(s)

Morphine

Primary Outcome Measure Information:

Title

Pain Scores on the Visual Analog Scale

Description

Correlation between the VAS Scores and BMI will evaluated

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

guniz koksal, Ass.Prof

Phone

2124143000

Ext

21876

gunizkoksal@hotmail.com

Facility Information:

Facility Name

Cerrahpasa Medical School

City

Istanbul

State/Province

Marmara

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

emre erbabacan, specialist

Phone

00905322067777

emreerbabacan@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

10782177

Citation

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. doi: 10.1381/096089200321668703.

Results Reference

background

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VAS Correlation With BMI

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