| CTRI Number |
CTRI/2026/01/101161 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| 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
|
A study comparing two medicines (dexmedetomidine and dexamethasone) added to a local anaesthetic (bupivacaine) for pain relief in patients undergoing lower back spine surgery. |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and dexamethasone as adjuvant to 0.25 percent Bupivacaine in erector spinae plane block for pateints undergoing posterior lumbar spine fixation surgery |
| 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 Kanika Pradhan |
| Designation |
Postgraduate resident |
| Affiliation |
Mahatma Gandhi Medical college and Hospital |
| Address |
Mahatma Gandhi Medical college and Hospital OT complex second floor Department of anesthesia , main hospital buildingRIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
8949095992 |
| Fax |
|
| Email |
pradhankanika97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubham Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical college and Hospital OT complex second floor Department Of Anestheisa main hospital building RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9799052551 |
| Fax |
|
| Email |
Shubham.kh29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical college and Hospital OT complex second floor Department of Anestheisa main hospital building RIICO Industrial Area Mahatma Gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9799052551 |
| Fax |
|
| Email |
Shubham.kh29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care ,Mahatma Gandhi Hospital Sitapura Jaipur Rajasthan |
| 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 Kanika Pradhan |
Mahatma Gandhi Hospital |
OT complex Department Of Anaesthesia Mahatma Gandhi Hospital Sitapura Jaipur
Jaipur
RAJASTHAN |
8949095992
Pradhankanika97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
| Intervention |
Comparison of Dexmedetomidine and dexamethasone as
adjuvant to 0.25%bupivacaine in erector
spinae plane block for patients undergoing posterior lumbar
spine fixation surgery |
Patients will be selected for undergoing lumbar spine surgery will be grouped into 2 groups on 35 each , Group Dexmedetomidine and Dexamethasone and USG guided Erector spinae block is given at the spinal level according to surgery. |
| Comparator Agent |
Using dexamethasone as adjuvant to 0.25 percent Bupivacaine in erector spinae plane block for patient undergoing posterior lumbar spine fixation surgery . |
Using Dexamethasone 8 mg as adjuvant to 0.25 percent Bupivacaine (40 ml) bilaterally in erector spinae plane block for patients undergoing posterior lumbar spine fixation surgery |
| Comparator Agent |
Using Dexmedetomidine as adjuvant to 0.25 percent Bupivacaine in erector spinae plane block for patients undergoing lumbar spine fixation surgery |
Using 1 mcg/kg dexmedetomidine with 0.25%bupivacaine (40 ml) bilaterally for erector spinae plane block in patients undergoing posterior lumbar spine fixation surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective posterior lumbar spine surgery needing general anaesthesia
Patients of all genders
Patient aged between 18-65 years
Patient with American Society of anaesthesiologists (ASA) Class I and II
|
|
| ExclusionCriteria |
| Details |
BMI more then 35
Patient with newly diagnosed coagulopathy
Patient with history of drug allergy
More then one attempt at ESP block
Inability to provide written consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post operative analgesia ,post operative opioid consumption ,amount of rescue analgesia ,post surgical stay ,post operatove nausea vomiting |
To compare the hemodynamics like SBP DBP ,MAP SPO2 Heart Rate and pain score at 0 /2/6/12/24 hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the Postoperative opioid consumption, amount of rescue analgesia use, post-surgical hospital stay and (PONV) postoperative nausea and vomiting
To observe adverse effect related to study drug if any
|
|
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
24/01/2026 |
| 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="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
|
This prospective randomised study aims to compare the analgesic efficacy of dexmedetomidine and dexamethasone as adjuvants to 0.25 percent Bupivacaine in ultrasound guided erector spinae plane block in patients undergoing lumbar spine fixation surgery.The study will evaluate post operative pain relief and analgesic requirements between two groups. |