VAS Correlation With BMI
Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 8, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedDecember 20, 2013
December 1, 2013
4 months
December 8, 2013
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Scores on the Visual Analog Scale
Correlation between the VAS Scores and BMI will evaluated
48 hours
Study Arms (5)
Group 5
ACTIVE COMPARATORPatients with BMI \> 50
Group IV
ACTIVE COMPARATORPatients with BMI between 40 and 49.9
Group III
ACTIVE COMPARATORPatients with BMI between 35 and 39.9
Group II
ACTIVE COMPARATORpatients with BMI between 30 and 34.9
Group I
ACTIVE COMPARATORPatients with BMI \<30
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.
You may not qualify if:
- patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cerrahpasa Medical School
Istanbul, Marmara, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 10782177BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assc.Prof
Study Record Dates
First Submitted
December 8, 2013
First Posted
December 20, 2013
Study Start
November 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 20, 2013
Record last verified: 2013-12