| CTRI Number |
CTRI/2026/03/106392 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing General Anaesthesia alone and General Anesthesia with Bilateral Erector Spinae Block with their effects on Stress Biomarkers After Spine Surgery. |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY ON THE EFFECT OF TWO ANAESTHETIC TECHNIQUES ON VARIOUS LABORATORY BIOMARKERS AFTER SPINE SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHINTA RAMYAKRISHNA |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesia
Subharti Medical College
Subharti University
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8688622536 |
| Fax |
|
| Email |
ramyach174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANORANJAN KR BANSAL |
| Designation |
Professor |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesia
Subharti Medical College
Subharti University
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7500693131 |
| Fax |
|
| Email |
dr.manojbansal7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANORANJAN KR BANSAL |
| Designation |
Professor |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesia
Subharti Medical College
Subharti University
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7500693131 |
| Fax |
|
| Email |
dr.manojbansal7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Medical College, Subharti University, Meerut-250005 |
|
|
Primary Sponsor
|
| Name |
Chinta Ramyakrishna |
| Address |
Dept of Anaesthesia, Subharti Medical college, meerut-250005 |
| Type of Sponsor |
Other [Myself] |
|
|
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 CHINTA RAMYAKRISHNA |
Chhatrapati Shivaji Subharti Hospital |
Chhatrapati Shivaji Subharti Hospital, Subharti University
Meerut
Meerut
UTTAR PRADESH |
8688622536
ramyach174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE MEDICAL, SWAMI VIVEKANAND SUBHARTI UNIVERSITY SUBHARTIPURAM, MEERUT, UTTAR PRADESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General Anaesthesia + Errector Spinae Block |
Errector Spinae Block will be given after General Anaesthesia and stress biomarkers are observed Post Operatively After 3 days |
| Comparator Agent |
General Anaesthesia Only in Spine Surgeries |
General anaesthesia is given in spine surgeries and stress biomarkers are obsevred post operatively After 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ammerican Society of Anaesthesiologists ASA physical status I–III
All patients admitted in CSSH scheduled to undergo spine surgeries.
|
|
| ExclusionCriteria |
| Details |
1.Type I or type II diabetes.
2.Oral contraceptives or Oestrogen therapy.
3.Body mass index more than 40 kg/m2.
4.Chronic analgesic therapy.
5.History of opioid dependence.
6.Those who receiving anticoagulation or experiencing any bleeding disorder.
7.Patients who required repeated surgical interventions.
8.Patient using chronic analgesic medication.
9.Psychiatric disorder.
10.Severe Hepatic , renal and neurological disease.
11.Emergency operation.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the effect of two anaesthetic techniques (General Anaesthesia alone vs General Anaesthesia combined with Ultrasound-guided Erector Spinae Plane Block) on various laboratory biomarkers (testosterone,cortisol, CRP, glucose) in patients undergoing spine surgeries. |
1.Glucose preoperative and postoperative after 6 hours
2.Testosterone, Cortisol, CRP preoperative and postoperative after 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the haemodynamic parameters: Mean arterial pressure and Heart rate.
2.To assess the association between the anaesthetic technique in post operative pain score(VAS).
|
1.Heart rate and Mean Arterial Pressure will be monitored immediately postop and then at 15 min, 30 min, 45 min, 60 min, 2nd hour ,6th hour, 12th hour, and 24th hour post operatively.
2. Assessment of pain was done using VAS(Visual Analogue Scale) immediately and then at 15 min, 30 min, 45 min, 60 min, 2nd hour , 6th hour, 12th hour and 24th hour after surgery. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/04/2026 |
| 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="2"
Months="0"
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
|
Spine surgeries are long and stressful. the patients suffer post operative stress and pain severely. This study is directed towards comparing stress markers and post operative pain and hemodynamic parameters in patients undergoing spine surgery under general anaesthesia with erector spinae block and without the block. Previous studies have shown beneficial effects with erector spinae block. |