| CTRI Number |
CTRI/2024/02/062895 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of ultrasound guided subcostal quadratus lumborum block and ilioinguinal-iliohypogastric nerve block to reduce post op pain in adult patients requiring anterior iliac crest autogenous bone graft harvesting -A prospective, randomised and comparative pilot study |
|
Scientific Title of Study
|
The efficacy of ultrasound guided subcostal quadratus lumborum block and ilioinguinal-iliohypogastric nerve block for donor site analgesia in adult patients requiring anterior iliac crest autogenous bone graft harvesting -A prospective, randomised and comparative pilot 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 Malarvizhi R |
| Designation |
fellow in regional anaesthesia |
| Affiliation |
ganga medical center and hospital |
| Address |
Department of anaesthesiology,
313 , mettupalayam road ,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9865960174 |
| Fax |
|
| Email |
rmalarvizhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tuhin Mistry |
| Designation |
Consultant |
| Affiliation |
Ganga Hospital |
| Address |
Department of anaesthesiology,
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India.
Department of anaesthesiology,
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
8240823526 |
| Fax |
|
| Email |
tm.tuhin87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tuhin Mistry |
| Designation |
Consultant |
| Affiliation |
Ganga medical centre and hospital |
| Address |
Department of anaesthesiology,
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India.
Department of anaesthesiology,
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
8240823526 |
| Fax |
|
| Email |
tm.tuhin87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Center and Hospital |
|
|
Primary Sponsor
|
| Name |
Ganga Hospital |
| Address |
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India. |
| 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 |
| Dr Tuhin Mistry |
Ganga medical centre and hospital |
Department of anaesthesiology, A BLOCK ,
313, Mettupalayam Road,
Coimbatore - 641 043.
Tamil Nadu, India.
Coimbatore
TAMIL NADU |
8240823526
tm.tuhin87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board, Ganga Hospital, Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (3) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided nerve block in patient undergoing anterior iliac crest bone grafting |
one group receives subcostal quadratus lumborum
other group receives ilio inguinal and ilio hypogastric nerve block |
| Comparator Agent |
ultrasound guided subcostal Quadratus Lumborum block and Illiohypogastric-illioinguinal nerve blocks
nerve block in patient undergoing anterior iliac crest bone grafting |
one group will receive subcostal quadratus lumborum other group will receives ilio inguinal and ilio hypogastric nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients who are willing to give informed consent
ASA grade 1 & 2
|
|
| ExclusionCriteria |
| Details |
patient refusal
patient allergic to local anaesthetic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of donor site analgesia in patients requiring anterior iliac crest autogenous bone graft harvesting |
Post operative period upto 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesics required, rescue analgesia, Pain score comparison, complications (if any) |
Post operative period upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/03/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This pilot study will involve the patients undergoing autologous anterior iliac crest bone grafting who are given either subcostal quadratus lumborum or ilio inguinal and iliohypogastric nerve block. This study aims to compare the analgesic efficacy of subcostal quadrates lumborum vs ilio inguinal and iliohypogastric nerve block.
The primary and secondary outcome parameters will be compared.
|