| CTRI Number |
CTRI/2024/12/078311 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| 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 to compare effects of 2 drugs for pain management in patients undergoing lumbar surgery |
|
Scientific Title of Study
|
A Randomised Comparative Study to Compare the Efficacy of Dexmedetomidine Vs Dexamethasone as an Adjuvant with Ropivacaine in Erector Spinae Block in Lumbar Spine Surgery Under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D R Binay Teja Reddy |
| Designation |
PG Student |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9182420631 |
| Fax |
|
| Email |
binayteja15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigisha Mehta |
| Designation |
Associate Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8866718168 |
| Fax |
|
| Email |
jbmehta.28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigisha Mehta |
| Designation |
Associate Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8866718168 |
| Fax |
|
| Email |
jbmehta.28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre |
| Address |
Waghodiya, Pipariya, Vadodara, Gujarat, 391760 |
| 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 DR Binay Teja Reddy |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT |
9182420631
binayteja15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth 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 |
dexamethasone |
0.375% ropivacaine 20ml + 4mg dexamethasone in erector spinae plane block on both sides.It will be given before surgery. Duration of intervention will be approximately 10 min. |
| Intervention |
dexmedetomidine |
0.375% ropivacaine 20ml + 25mcg dexmedetomidine in erector spinae plane block on both sides. It will be given before surgery. Duration of intervention will be approximately 10 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study,
Patients of ASA grade I, II, III of either gender,
Patients undergoing elective lumbar surgery,
Age of patients 18-75 years.
|
|
| ExclusionCriteria |
| Details |
Patients refusal,
Patient belonging to ASA IV, V GRADE,
Patients with bleeding and coagulation disorders,
Infection at the site.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing the VAS score, duration of analgesia and total rescue analgesia given |
After completion of surgery, then every 2 hourly till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing hemodynamic parameters, sedation score and complications |
Hemodynamic parameter- every 30 minutes till the completion of surgery, there after every 2 hourly upto 24 hours
Sedation score and complications- Every 2 hourly upto 24 hours. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="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
|
This study will help us to determine which drug is safe and provides longer duration of analgesia in patients undergoing lumbar spine surgery. |