| 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
|
|
|
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
|
|
|
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.
â— Patient not giving consent for the study.
â— Patients with known case of preoperative pain disorder/ Chronic pain
syndromes
â— History of chronic opioid use before surgery
â— Chronic steroid use
â— Revision surgeries
â— ASA more than III
â— Chronic renal insufficiency
â— 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
|
BackgroundBody 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 StudyThis 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: - Identify trends in pain severity among patients with varying BMI levels.
- Understand the potential impact of BMI on analgesic requirements and recovery timelines.
- 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. |