| CTRI Number |
CTRI/2025/10/096229 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation Of Segmental Thoracic Spinal Anaesthesia Technique Versus General Anaesthesia Technique For Patients Undergoing Elective Umbilical And Supraumbilical Hernia Surgeries For The Hemodynamic Parameters |
|
Scientific Title of Study
|
Comparison of segmental thoracic spinal anaesthesia and general anaesthesia in umbilical and supraumbilical hernia 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 |
Rajvardhan Singh |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9131839659 |
| Fax |
|
| Email |
rajvsingh30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima Batra |
| Designation |
Professor And Head Of The Department of Anaesthesiology |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajvardhan Singh |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9131839659 |
| Fax |
|
| Email |
rajvsingh30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples Hospital Bhopal |
| Address |
Ayodhya Bypass Road Bhanpur Bhopal Madhya Pradesh India 462037 |
| 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 Rajvardhan Singh |
Peoples Hospital |
Room no 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9131839659
rajvsingh30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College Of Medical Sciences And Research Centre By Pass Road Bhanpur Bhopal 462037 M P Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia |
The Patient Posted For Both Elective Umbilical And Supraumbilical Hernia Sugeries, After Pre Oxygenation With 100 Percent Oxygen For 3 Minutes, Injection Glycopyrrolate 2 To 4 mcg Per kg, Injection Ondansetron 0.1 mg Per kg, Injection Midazolam 0.1 To 0.2 mg Per kg, Injection Fentanyl 1 To 2 mcg Per kg, Patients Will Be Induced With Injection Propofol 2 mg Per Kg And Injection Atracurium 0.5-0.6 mg Per kg. Anaesthesia Will Be Maintained With Oxygen, Nitrous Oxide, Isoflurane And Injection Atracurium 0.1 mg Per kg And Paracetamol 1 Gram Intravenously As Required. After The Completion Of The Said Surgery, Patients Will Be Reversed With Injection Glycopyrrolate 0.01 mg Per kg And Injection Neostigmine 0.05 mg Per kg And Extubated. |
| Intervention |
Segmental Thoracic Spinal Anaesthesia |
In Patients Posted For Elective Umbilical And Supraumbilical Hernia Surgeries, Segmental Thoracic Spinal Anaesthesia Will Be Given By A 25G Quicke Needle At T10 Level With Injection 0.5 Percent Isobaric Levobupivacaine 6.25 Mg (1.25ml) With Injection Fentanyl 25 Mcg Administered At A Speed Of 0.2 ml Per second. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II
Patients Scheduled For Elective Umbilical And Supraumbilical Hernia Surgeries
|
|
| ExclusionCriteria |
| Details |
Patient Refusal
Age Less Than 18 Years And More Than 65 Years
ASA Grade III Or More
BMI More Than 35 Kg Per m2
Patients With Uncorrected Hypovolemia Or Shock
Patients With Raised Intracranial Pressure
Patients With Abnormal Coagulation Profile
Patients With Hypersensitivity To Any Of The Drugs Used
Pregnant And Lactating Mother
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe Hemodynamic Parameters And Post-Operative Recovery In Patients Undergoing Segmental Thoracic Spinal Anaesthesia And General Anaesthesia and To Compare Between The Observations Of The Two Groups |
Upto 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time needed for rescue analgesia in the two groups |
Upto 6 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2025 |
| 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 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
|
Patients will be divided into 2 groups, Group S receiving Segmental Thoracic Spinal Anaesthesia and Group G receiving General Anaesthesia.
In Group S, the patients posted for elective umbilical and supraumbilical hernia surgeries, STSA will be given by a 25G Quincke’s Needle at T10 level with Injection 0.5% Isobaric Levobupicavaine 6.25 mg (1.25ml) with Injection Fentanyl 25 mcg administered at a speed of 0.2 ml/second. Sensory effect will be measured by pin prick method.
In Group G, the patients posted for both elective umbilical and supraumbilical hernia surgeries, after pre oxygenation with 100% oxygen for 3 minutes, injection Glycopyrrolate 2-4 mcg/kg, Injection Ondansetron 0.2 mg/kg, Injection Midazolam 0.1-0.2 mg/kg, Injection Fentanyl 1-2 mcg/kg, patients will be induced with Injection Propofol 2 mg/kg and Injection Atracurium 0.5-0.6 mg/kg. Anaesthesia will be maintained with Oxygen, Nitrous Oxide, Isoflurane and injection Atracurium 0.1mg/kg and Paracetamol 1 gm intravenously as required. After the completion of the said surgery, patients will be reversed with Injection Glycopyrrolate 0.01 mg/kg and Injection Neostigmine 0.05 mg/kg and extubated.
The hemodynamic parameters will be noted down at the time of injection (0 minutes), at 2 minutes, at 5 minutes, 10 minutes, 15 minutes, 30 minutes and 1 hour, 2 hour, 4 hour, 6 hour. VAS Scoring will be done postoperatively at 1 hour, 2 hour,4 hours, and 6 hours respectively. Time required opr rescue analgesia will be noted in both the groups. Perioperative complication will be noted and managed if any. |