VAS Correlation With BMI

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02017314
• Other study ID #: 830458909
• Status: Recruiting
• Phase: Phase 4
• First received: December 8, 2013
• Last updated: December 16, 2013
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2013
• Source: Istanbul University
• Contact: guniz koksal, Ass.Prof
• Phone: 2124143000
• Email: gunizkoksal[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• Morphine

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical School	Istanbul	Marmara

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Visual Analog Scale	Correlation between the VAS Scores and BMI will evaluated	48 hours	No