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CTRI Number  CTRI/2024/12/078000 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out how body weight affects the severity of pain after abdominal surgeries 
Scientific Title of Study   Cross sectional study on association between body mass index and severity of postoperative pain among patients undergoing abdominal surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manju Anmaria Baby 
Designation  Postgraduate student (MD Anaesthesia) 
Affiliation  Sree Balaji medical College and hospital  
Address  Department of Anaesthesia Third floor Hospital Block Sree balaji medical college and hospital 7 CLC works road Shankar nagar Chrompet chennai Tamilnadu 600044

Kancheepuram
TAMIL NADU
600044
India 
Phone  9847223397  
Fax    
Email  manjuanmaria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetha soundarya  
Designation  Associate professor  
Affiliation  Sree Balaji medical College and hospital  
Address  Department of Anaesthesia Third floor Hospital Block Sree balaji medical college and hospital 7 CLC works road Shankar nagar Chrompet chennai Tamilnadu 600044

Kancheepuram
TAMIL NADU
600044
India 
Phone  9444570135  
Fax    
Email  gsound15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha soundarya  
Designation  Associate professor  
Affiliation  Sree Balaji medical College and hospital  
Address  Department of Anaesthesia Third floor Hospital Block Sree balaji medical college and hospital 7 CLC works road Shankar nagar Chrompet chennai Tamilnadu 600044

Kancheepuram
TAMIL NADU
600044
India 
Phone  9444570135  
Fax    
Email  gsound15@gmail.com  
 
Source of Monetary or Material Support  
Sree Balaji medical College and hospital 7 CLC works road Shankar Nagar chrompet Chennai Tamilnadu  
 
Primary Sponsor  
Name  Sree balaji medical college and hospital  
Address  Sree balaji medical college and hospital 7 CLC works road Shankar nagar chrompet chennai Tamilnadu 600044 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Geetha Soundarya  Sree Balaji medical College and hospital   Department of Anaesthesia Third floor Hospital block Sree Balaji medical College and hospital 7 CLC works road Shankar Nagar chrompet Chennai Tamilnadu
Kancheepuram
TAMIL NADU 
09444570135

gsound15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sree Balaji medical College and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C170||Malignant neoplasm of duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. age group of 18-80 years who underwent a major surgical procedure under general or regional
anaesthesia
2. ASA status I-III 
 
ExclusionCriteria 
Details  Age less than 15 years and older than 80 years.
● Patient not giving consent for the study.
● Patients with known case of preoperative pain disorder/ Chronic pain
syndromes
● History of chronic opioid use before surgery
● Chronic steroid use
● Revision surgeries
● ASA more than III
● Chronic renal insufficiency
● Procedures done under local anaesthesia 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Severity of Post operative pain using Numerical Rating Score  0,6,12,24,48 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Morphine Equivalents used for as rescue analgesia  0,6,12,24,48 hours after surgery 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background

Body Mass Index (BMI) has been identified as a key determinant in various health outcomes, including surgical recovery and post-operative pain management. Higher BMI levels are associated with physiological alterations, such as increased adipose tissue and systemic inflammation, which can affect pain perception and healing processes. Abdominal surgery, given its significant impact on the musculoskeletal and nervous systems, presents a unique context in which BMI may play a critical role in influencing post-operative pain severity. Despite advancements in pain management techniques, patients with higher BMI often report greater pain intensity, increased opioid consumption, and prolonged hospital stays. The precise mechanisms linking BMI to post-operative pain, however, remain inadequately understood, necessitating further research.

Purpose of the Study

This study aims to explore the association between Body Mass Index (BMI) and the severity of post-operative pain in patients undergoing abdominal surgery. By analyzing pain scores, opioid consumption, and recovery parameters across different BMI categories, the study seeks to:

  1. Identify trends in pain severity among patients with varying BMI levels.
  2. Understand the potential impact of BMI on analgesic requirements and recovery timelines.
  3. Provide data-driven insights to optimize perioperative pain management strategies tailored to patients with higher BMI.

Ultimately, the findings of this study may help improve personalized care and enhance surgical outcomes for patients undergoing abdominal surgery, particularly those with elevated BMI.

 
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