| CTRI Number |
CTRI/2022/01/039249 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFICACY OF TWO BLOCKS FOR LUMBAR DISECTOMY SURGERIES |
|
Scientific Title of Study
|
“COMPARISON OF EFFICACY OF ULTRASOUND-GUIDED ERECTOR SPINAE BLOCK VERSUS ULTRASOUND-GUIDED THORACOLUMBAR INTERFASCIAL PLANE BLOCK FOR PERIOPERATIVE ANALGESIA IN LUMBAR DISCECTOMY SURGERIES†|
| Trial Acronym |
UGESBVUGTIPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GOKULAKANNAN M |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF MEDICAL SCIENCES,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8056567635 |
| Fax |
|
| Email |
gokulakannan95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A P SINGH |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF MEDICAL SCIENCES,BHU
Varanasi
UTTAR PRADESH
221995
India |
| Phone |
9839412975 |
| Fax |
|
| Email |
bhuapsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHINAY JAYANTI |
| Designation |
Assistant Professor |
| Affiliation |
Institute of medical sciences |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF MEDICAL SCIENCES,BHU
Varanasi
UTTAR PRADESH
221995
India |
| Phone |
7379141929 |
| Fax |
|
| Email |
abhinay2288@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical sciences, Banaras hindu University,Varanasi |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Institute of medical sciences,Banaras hindu University,Varanasi-221005 |
| 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 Gokulakannan |
Trauma centre and superspecialty hospital,IMS,BHU |
Department of anaesthesiology,Institute of medical sciences (IMS),BHU
Varanasi
UTTAR PRADESH |
8056567635
gokulakannan95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Faculty of medicine,Institute of medical sciences,Banaras hindu University |
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 |
| Intervention |
Erector spinal block |
USG guided erector spinae block will be performed at the level of third lumbar vertebra with 20ml of 0.2% ropivacaine with dexmeditomedine 1mcg/kg |
| Comparator Agent |
Thoracolumbar interfacial plane block |
USG guided thoracolumbar interfascial plane block will be performed at the level of third lumbar vertebra with 20 ml 0.2% ropivacaine with dexmeditomedine 1mcg/kg |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1,2
Cases of prolapsed intervertebral disc(PIVD) undergoing disectomy |
|
| ExclusionCriteria |
| Details |
Patient’s age <25 years and >50 years.
Patients with Bleeding diasthesis.
Patient allergic to LA agents.
Patients with Psychiatric disorders.
Presence of infection at the injection area.
Patients with H/O previous spine surgeries.
Refusal of consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
30 minutes,hours 1,6,12,24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesia requirement in 24 hours |
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be conducted in Department of Anaesthesiology, IMS, BHU,Varanasi after obtaining written and informed consent and institutional ethical approval. After CTRI registration,60 patients undergoing lumbar disectomy surgeries, of age 25 to 50 years will be included. Patients will be excluded from study if patient has local infection or significant coagulopathy/bleeding disorders,allergy to Local anaesthetics,psychiatric disorders,history of previous spine surgery and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelop technique into two equal groups.Group (E) will receive USG guided erector spinae block at the level of third lumbar vertebra with 20ml of 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.
Group (T) will receive USG guided thoracolumbar interfascial plane block at the level of third lumbar vertebra with 20 ml 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.
After 20 minutes,block effect will be checked and those patients for whom block is unsuccessful ,will be excluded from the study. Then patient will be placed in supine position and anesthesia is induced with propofol 2 mg/kg titrated to effect plus fentanyl 2 mcg/kg will be administered for analgesia and muscle relaxation will be achieved with vecuronium 0.1 mg/kg following which oral endotracheal intubation will be done. Anesthesia will be maintained with isoflurane 1MAC and nitrous oxide in 30% oxygen.Inj.Fentanyl 1mcg/kg will be repeated every hourly intraoperatively.
For rescue analgesia in postoperative period,Injection tramadol 1mg/kg will be given.
In intraoperative period,hemodynamic parameters (Heart rate,systolic/diastolic/mean blood pressure) will be monitored at minutes 3,5,15,30,60,then hourly,total fentanyl consumption intraoperatively and duration of surgery are noted.
In postoperative period,VAS score will be monitored at 30 minutes,hours 1,6,12,24 (at rest and in motion),time for requirement of first rescue analgesia,total rescue analgesia needed in 24 hours,block related complications and time of mobilisation of patient are noted.
The study will end after mobilisation of patient,after all data has been collected. |