| CTRI Number |
CTRI/2025/09/094912 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study on skin temperature changes after spinal anesthesia in patients undergoing lower abdominal surgery. |
|
Scientific Title of Study
|
An observational study of peripheral skin temperature changes following spinal anesthesia in lower abdominal surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S HARITHA |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of anesthesiology, Main OT complex, 13-A, Pondy villupuram main road, Sri Venketeshwara Medical college hospital and research center
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8778141301 |
| Fax |
|
| Email |
harisaravan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARITHA |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,MAIN OT COMPLEX,13 A,PONDY,VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE,
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13-A, PONDY-VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY.
PONDICHERRY
INDIA
PONDICHERRY
605102
India |
| Phone |
8778141301 |
| Fax |
|
| Email |
harisaravan99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHARITHA |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,MAIN OT COMPLEX,13 A,PONDY,VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE,
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13-A, PONDY-VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY.
PONDICHERRY
INDIA
PONDICHERRY
605102
India |
| Phone |
8778141301 |
| Fax |
|
| Email |
harisaravan99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venketeshwara medical college and hospital and research center pondicherry |
|
|
Primary Sponsor
|
| Name |
DR S HARITHA |
| Address |
Department of anesthesiology, Main OT complex 13-A Pondy villupuram main road, Sri venketeshwara medical college hospital and research center. |
| Type of Sponsor |
Private medical college |
|
|
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 R JAYASHRI DEVI |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India
Pondicherry
PONDICHERRY |
8754689690
dr.jayashridevi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGY CLASS 1 AND 2 PATIENTS PLANNED FOR ELECTIVE LOWER ABDOMINAL SURGERIES UNDER SPINAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
Refusal to consent
Known peripheral vascular disease
Uncontrolled Diabetic mellitus and hypertensive disorders
Febrile illness
Patient on vasodilators. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peripheral skin temperature in the dorsum of both the feet significantly increases following spinal anesthesia in patient undergoing lower abdominal surgeries, reflecting the onset and extent of bilateral sympathetic blockade. |
Baseline(Before spinal anesthesia)immediately after spinal injection at 1,5,10,15,45 minutes.Every 30 min there after until the end of surgery or regression of block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THIS OBSERVATIONAL STUDY EVALUATES PERIPHERAL SKIN TEMPERATURE CHANGES FOLLOWING SPINAL ANAESTHESIA IN LOWER ABDOMINAL SURGERIES.SPINAL ANAESTHESIA CAUSES SYMPATHETIC BLOCKADE LEADING TO VASODILATATION AND RISE IN SKIN TEMPERATURE.BY MONITORING THESE CHANGES AND CORELATING THEM WITH BLOCK LEVEL .THE STUDY EXPLORES SKIN TEMPERATURE AS A SIMPLE NON INVASIVE MARKER FOR ASSESSING ADEQUACY OF SPINAL BLOCK |