| CTRI Number |
CTRI/2025/12/099067 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Morphine for Postoperative pain in Spine surgery |
|
Scientific Title of Study
|
Comparison Of Post operative Analgesia Of Intrathecal Morphine with Erector Spinae Plane Block Versus Intrathecal Morphine in Spine Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1332-7342 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
2nd Floor Department of anaesthesia Teerthankar Mahaveer Medical College Bagadpur Delhi Road
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
2nd Floor Department of anaesthesia Teerthankar Mahaveer Medical College Bagadpur Delhi Road
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
2nd Floor Department of anaesthesia Teerthankar Mahaveer Medical College Bagadpur Delhi Road
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Teerthankar Mahaveer Medical College |
| Address |
Department of anaesthesia,Teerthankar Mahaveer Medical College,Bagadpur ,moradabad uttar pradesh |
| 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 mukesh Kumar Prasad |
Teerthankar Mahaveer Medical College |
Room no: 1 surgery Operation theatre Department of Anaesthesia,244001
Moradabad
UTTAR PRADESH
Moradabad
UTTAR PRADESH |
9837624543
mukeshkumar2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,Teerthanker Mahaveer University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal Morphine with Erector Spinae Plane Block in Spine Surgeries just before administration of General Anaesthesia |
After positioning the patient prone , under aseptic precautions
20ml of 0.25 % bupivacaine + 50 mcg of ITM will be injected at the level above/below the vertebral fracture under USG guidance. |
| Comparator Agent |
Intrathecal Morphine in Spine Surgeries just before administration of General Anaesthesia |
After positioning the patient prone , under aseptic precautions
150 mcg of ITM will be injected at the level above/below the vertebral fracture
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patient given written and informed consent.
-American Society of Anesthesiologist (ASA) grade I-II of either sex.
-Age group of 18-65 years old Undergoing elective spine surgeries under general anesthesia.
|
|
| ExclusionCriteria |
| Details |
-Obstructive sleep apnea , respiratory diseases
-Allergy to morphine or bupivacaine
-Local skin infections
-Emergency or unplanned surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes (MAP SBP DBP HR)
visual analogue scale (VAS)for pain
Complications (if any) |
At baseline,immediately after surgery at 1hour, 2hour, 4hour 6hour, 12hour, 18hour
and 24 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Time For First Rescue Analgesia
-Complications (if any) |
At baseline,immediately after surgery at 1hour, 2hour, 4hour 6hour, 12hour, 18hour
and 24 hour. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
After
positioning the patient prone under all aseptic precautions in
Group
A 150 mcg of ITM will be injected at the level above or below the vertebral
fracture In
Group
B 20ml of bupivacaine and 50 mcg of ITM will be injected at the level
above or below the vertebral fracture under USG guidance Intraoperative
monitoring and management will be done as per standard guidelines In
postoperative period patients will be assessed for pain by visual analogue
scale at 0 hour 2 hours 6 hours 12 hours and 24 hours postsurgery in both groups |