| CTRI Number |
CTRI/2023/07/054776 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of use of bupivacaine and ropivacaine with use of ultrasound in erector spinae block for poster operative pain relief in spine surgeries |
|
Scientific Title of Study
|
Comparison of Bupivacaine and Ropivacaine in Ultrasound-guided bilateral erector spine plane block for post-operative analgesia in lumbar 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 |
YAMUNA KRISHNAN |
| Designation |
Postgraduate |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road, New Delhi-110001
India
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road,New Delhi- 110001
India
Central
DELHI
110001
India |
| Phone |
8076978617 |
| Fax |
|
| Email |
ykrishnan2201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ALKA GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road,New Delhi-110001
India
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road, New Delhi-110001
India
Central
DELHI
110001
India |
| Phone |
9871653335 |
| Fax |
|
| Email |
alkagupta_rml@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
YAMUNA KRISHNAN |
| Designation |
Postgraduate |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road, New Delhi-110001
India
ABVIMS and Dr.RML Hospital, Baba Kharak Singh road, New Delhi-110001
India
Central
DELHI
110001
India |
| Phone |
8076978617 |
| Fax |
|
| Email |
ykrishnan2201@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr.RML Hospital |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr.RML Hospital |
| Address |
ABVIMS and Dr.RML Hospital
Baba Kharak Singh road Connnaught place
New Delhi 110001 |
| 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 |
| Yamuna Krishnan |
ABVIMS and Dr. RML Hospital |
Department of Anaesthesia, ABVIMS and Dr RML Hospital
Baba Kharak Singh
New Delhi 110001
Central
DELHI |
8076978617
ykrishnan2201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ABVIMS and Dr.RML Hospital, NEW DELHI |
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 |
Ultrasound-guided bilateral erector spinae plane block for post operative analgesia in lumbar spine surgery |
Use of 0.2% Ropivacaine for erector spinae plane block |
| Intervention |
Ultrasound-guided bilateral erector spinae plane block for post operative analgesia in lumbar spine surgery |
Use of 0.25% Bupivacaine for erector spinae plane block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II,Patients posted for lumbar spine surgery |
|
| ExclusionCriteria |
| Details |
Patients not consenting to the procedure
Local infection at the block site
Pre- existing coagulation disorders
Allergy to local anesthetics (prior test dosing with Bupivacaine and ropivacaine will be given) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia,time between institution of block and requirement of first rescue analgesia |
Before shifting to PACU
Immediately after shifting to PACU
30 minutes
1st hour
1.5 hour
2nd hour
4th hour
6th hour
8th hour
10th hour
12 th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative hemodynamic parameters
Post operative nausea vomiting and any other adverse effects |
Before shifting to PACU
Immediately after shifting to PACU
30 minutes
1st hour
1.5 hour
2nd hour
4th hour
6th hour
8th hour
10th hour
12 th hour |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the efficacy of bupivacaine and ropivacaine in ultrasound guided erector spinae block for providing post operative analgesia in lumbar spine surgery |