| CTRI Number |
CTRI/2024/10/075346 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of Erector Spinae Plane Block and
Thoracolumbar Interfascial Plane Block for pain control in
patient undergoing lumbar spine surgery. |
|
Scientific Title of Study
|
Comparison of erector spinae plane block and
thoracolumbar interfascial plane block for pain control in
patient undergoing lumbar spine surgery - a prospective randomized controlled clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adella Majaw |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
700020
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
8258900235 |
| Fax |
|
| Email |
adicjj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maitreyee Mukherjee |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
700020
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maitreyee Mukherjee |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
700020
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post Graduate Medical Education and Research, 244, AJC Bose Road, Kolkata-700020 |
| 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 Adella Majaw |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Anaesthesiology, 3rd floor, Main Block, 244 AJC Bose Road, Kolkata-700020
Kolkata
West Bengal
Kolkata
WEST BENGAL |
8258900235
adicjj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight 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 |
| Intervention |
Erector Spinae Plane Block. |
To determine the effect of Erector Spinae Plane Block in terms of pain management and analgesic requirement in patients undergoing lumbar spine surgery, during the intra-operative and post-operative periods. |
| Comparator Agent |
Modified Thoracolumbar Interfascial Plane Block |
To determine the effect of Modified Thoracolumbar Interfascial Plane Block in terms of pain management and analgesic requirement in patients undergoing lumbar spine surgery, during the intra-operative and post-operative periods. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients undergoing elective OT, ASA I-llI, involving more than 1 level but less than 3 level of spine.
2)Providing written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.history of bleeding diathesis
2.receiving anticoagulant treatment
3. known allergies to medications used in the study (local anesthetics, nonsteroidal anti-inflammatory drugs, and opioids)
4.skin infections at the site of block area 5.pregnancy or lactation
6.refusal to participate in the study.
7.Redo surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time duration up to first request for rescue analgesia. (Fentanyl-50 μg) |
Postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Intraoperative requirement of fentanyl
2)Total Tramadol consumption in first 24 hours in the postoperative period
3)Complications-bleeeding, hematoma, local anaesthetic toxicity,
4)pneumothorax, pruritus, nausea, vomiting.
|
Perioperative Period. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lumbar spine surgery has been known to be associated with acute severe
pain, intraoperatively and postoperatively as well. ESP block and mTLIP block are two of the most recent techniques developed
in 2015-2016. It has been seen in various researches, that mTLIP block and ESP
block are both effective in relieving pain and decreasing the consumption of
opioids in lumbar surgery. Therefore, which block is superior when it comes to the provision
of analgesia, leading to reduction in opioids consumption perioperatively will be
assessed in this study.
|