| CTRI Number |
CTRI/2020/12/029729 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
09/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ultrasound guided low thoracic erector spine plane block for perioperative analgesia in lumbar spine surgeries |
|
Scientific Title of Study
|
Ultrasound guided low thoracic erector spine plane block for perioperative analgesia in lumbar spine surgeries under general anaesthesia |
| Trial Acronym |
USG ESP BLOCK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandhya G R |
| Designation |
Postgraduate medical student |
| Affiliation |
Bangalore medical college and Research institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and Research institute, krishna rajendra Road, Bengaluru-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9740021527 |
| Fax |
|
| Email |
Sandhyagowli3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha C |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and Research institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and Research institute, krishna rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9845489724 |
| Fax |
|
| Email |
Suri.c13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surekha C |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and Research institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and Research institute, krishna rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9845489724 |
| Fax |
|
| Email |
Suri.c13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and Research institute, krishna rajendra Road, bengaluru, karnataka - 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Sandhya G R |
| Address |
Department of Anaesthesiology, Bangalore medical college and Research institute, krishna rajendra Road, bengaluru |
| Type of Sponsor |
Government 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 Sandhya G R |
Dr Sandhya G R |
Department of Anaesthesiology, Bangalore medical college and Research institute, krishna rajendra Road, bengaluru
Bangalore
KARNATAKA |
9740021527
Sandhyagowli3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae block |
Low thoracic erector spinae block with 20 ml of the local anaesthetic injection Ropivacaine 0.2% |
| Intervention |
No erector spinae block |
Only conventional general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 -65years
2.Patient willing to give informed consent
3.Patient undergoing lumbar spine surgeries
4.Patients belonging to ASA 1 and 2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative analgesia |
10th minute, 20th minute, 30 th minute, 45th minute, 60th minute, 75th minute and 90th minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Haemodynamic stability
2)Consumption of rescue analgesia
3)adverse effects if any |
Perioperative and postoperative |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/12/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomized double blind control study comparing the efficacy of ultrasound guided low thoracic erector spinae block for perioperative analgesia in lumbar spine surgeries under general anaesthesia. It will be conducted in a total of 32 patients, 16 in each group, in all the hospitals attached to Bangalore medical college and Research institute. The primary outcome is to compare the analgesia between the study and control group. Haemodynamic stability and consumption of rescue analgesia will also be observed between the groups. |