| CTRI Number |
CTRI/2026/02/103604 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Of Postoperative Pain Relief in Lumbar Spine Surgery Patients |
|
Scientific Title of Study
|
A Comparative Study Of Bupivacaine Alone And Bupivacaine with Dexmedetomidine In Erector Spinae Plane Block For Postoperative Analgesia In Posterior Lumbar Spine 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 |
Dhara Ram |
| Designation |
Resident Doctor |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmadabad |
| Address |
Department Of Anaesthesia GCS Medical College hospital and research centre near chamunda bridge ahmedabad Ahmadabad
GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
7984147806 |
| Fax |
|
| Email |
ramdhara449@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Jadav |
| Designation |
Associate Professor,department of anaesthesia |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmadabad |
| Address |
Department Of Anaesthesia GCS Medical College hospital and research centre near chamunda bridge ahmedabad Ahmadabad
GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
7874145408 |
| Fax |
|
| Email |
drdeepa0202@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhara Ram |
| Designation |
Resident,department of anaesthesia |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmadabad |
| Address |
Department Of Anaesthesia GCS Medical College hospital and research centre near chamunda bridge ahmedabad Ahmadabad
GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
7984147806 |
| Fax |
|
| Email |
ramdhara449@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS medical College Hospital and Research Centre 380025 Ahmedabad,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
GCS medical College Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad, Gujarat,
India-380025
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Jadav |
Gujarat Cancer Society, medical College, Hospital and Research Centre |
Room No.105, Anaesthesia OPD,Department of anaesthesia Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
7874145408
drdeepa0202@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: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj.Bupivacaine(0.25%) 19 ml+ 1 ml NS |
Inj.Bupivacaine(0.25%)19 ml+ 1 ml NS will be given under USG machine guindance for ESP block in Patients undergoing Lumbar spine surgery |
| Intervention |
Inj.Bupivacaine(0.25%)19 ml+inj. Dexmedetomidine (0.5mcg/kg) |
Inj.Bupivacaine(0.25%)19 ml+inj.Dexmedetomidine (0.5mcg/kg) will be given under USG machine guindance for ESP block in Patients undergoing Lumbar spine surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Informed written consent
2.ASA Grade 1 to 3
3.Elective 1 or 2 level posterior Lumbar Spine Surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient refusing for consent
2.Infection at site of needle insertion
3.Coagulopathies
4.Known sensitivity or allergy to the study drugs
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulse
Systolic Blood Pressure
Diastolic Blood Pressure
Spo2 |
vitals will be observed intra op(Base line,After induction,
After Prone Position, At block
After block at 10 min,30 min
60 min,80 min,120 min,180 min)
And Post operatively(1hr,2hr,4hr,8hr,12hr,24hr) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain intensity using Numerical Rating Scale(NRS) |
1 hour
2 hour
4 hour
8 hour
12 hour
24 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
21/02/2026 |
| 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 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
|
Erector spinae plane block is a technique for providing postoperative analgesia in posterior lumbar spine surgeries.Bupivacaine use for this and provide analgesia adding dexmedetomidine will help to prolong duration of analgesia this study compares bupivacaine alone with bupivacaine plus dexmedetomidine in ESP block. Postoperative pain will be assessed using the Numerical Rating Scale, along with monitoring of vital parameters. |