| CTRI Number |
CTRI/2024/06/069481 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial comparing efficacy of two regional nerve blocks post operative pain relief in spine surgeries. |
|
Scientific Title of Study
|
A Randomized Control Trial Comparing the Efficacy of Ultrasound Guided Erector Spinae Plane Block with Thoracolumbar Interfacial Plane Block For Lumbar Spine Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Ratnam |
| Designation |
Post graduate |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
204/R block abode valley
54 Kakkar street Potheri
Chengalpattu .
Room no.209, B block,2nd floor,department of anaesthesiology,Srm medical college hospital and research institute,kattankulathur,Chengalpattu,Tamil Nadu,603203 ,india
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8789923313 |
| Fax |
|
| Email |
manisha.ratnam23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrK karthik |
| Designation |
Professor |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
2nd floor, 209, department of anaesthesiology ,Srm medical college hospital and research institute,kattankulathu,Chengalpattu, tamilnadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrK karthik |
| Designation |
Professor |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
2nd floor, 209, department of anaesthesiology ,Srm medical college hospital and research institute,kattankulathu,Chengalpattu, tamilnadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, Kattankulathur. Chengalpattu distt, Tamil Nadu, India PIN-603203 |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research centre |
| Address |
SRM medical college hospital and research centre,kattankulathur,Chengalpattu Distt,Tamil Nadu, India, PIN-603203 |
| 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 Manisha ratnam |
Department of anaesthesiology,SRM medical college hospital |
B/206 2ndfloor dept of anaesthesiology,Srm medical college hospital and research centre,kattankulathur,Chengalpattu,Tamil nadu
Kancheepuram
TAMIL NADU |
8789923313
manisha.ratnam23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S329||Fracture of unspecified parts of lumbosacral spine and pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ANATOMICAL LANDMARK |
ANATOMICAL LANDMARK BASED Erector spinae plane block and THoracolumbar interfascial plane nerve block |
| Intervention |
ultrasound |
ultrasound guided Erector spinae plane block and THoracolumbar interfascial plane block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA 1and 2 patients.
2)Age 18 to 65 yrs
3)patients of either sex
4)Patients who are undergoing elective lumbar spine surgeries. |
|
| ExclusionCriteria |
| Details |
1)Patients refusal.
2)ASA 3 and 4 Patients
3)Patients with deranged coagulation profile
4)patients allergic to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post operative analgesia between the two blocks. |
To compare the duration of post operative analgesia between the two blocks.Baseline,post intubation,10mins,20mins,30mins,40mins,50mins,60mins,70mins,80mins,90mins,100mins,110mins,120mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The number of doses of analgesics consumed in 24hrs. |
4hrs post op to 24hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
30/06/2024 |
| 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="4"
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
|
A total of 60 patients between 18-65yrs of asa1and asa2 undergoing elective lumbar spine surgeries will be prospectively studied in this single blinded randomised control trial.A total of 60 patients will be allocated into two groups group E and group T.Group E will receive usg guided erector spinae plane block and group T will receive usg guided thoracolumbar interfacial plane block.Both groups will receive block with 40ml of 0.375% ropivacaine,20ml on each side.All the patients will be assessed for primary outcome of post operative pain.Data collection will be done by observation and measurement of various parameters. |