| CTRI Number |
CTRI/2024/04/065080 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| 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
|
Postoperative effective analgesia in hip replacement surgery |
|
Scientific Title of Study
|
To Compare the Postoperative Analgesic effect of Ultrasound guided Anterior Quadratus Lumborum Block with Suprainguinal Fascia Iliaca Block in Patients undergoing Total Hip Replacement Surgery-A Randomised Comparative Prospective 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 Vinothkumar V |
| Designation |
DNB Post Graduate |
| Affiliation |
Ganga Medical Centre and Hospitals |
| Address |
Department of Anaesthesiology
Ganga Medical Centre and Hospitals
313 Mettupalayam Road
Coimbatore
Tamilnadu.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9894947781 |
| Fax |
|
| Email |
vinothvelusamy59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand N |
| Designation |
Senior Consultant |
| Affiliation |
Ganga Medical Centre and Hospitals |
| Address |
Department of Anaesthesiology
Ganga Medical Centre and Hospitals
313 Mettupalayam Road
Coimbatore
Tamilnadu.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9925422817 |
| Fax |
|
| Email |
drvivek@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand N |
| Designation |
Senior Consultant |
| Affiliation |
Ganga Medical Centre and Hospitals |
| Address |
Department of Anaesthesiology
Ganga Medical Centre and Hospitals
313 Mettupalayam Road
Coimbatore
Tamilnadu.
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9925422817 |
| Fax |
|
| Email |
drvivek@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospitals
313 Mettupalayam Road
Coimbatore
Tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Dr VINOTHKUMAR V |
| Address |
Ganga Medical Centre and Hospitals
313 Mettupalayam road
Coimbatore
Tamilnadu. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vinothkumar V |
Ganga Medical Centre and Hospitals |
Department of Anaesthesiology
Orthopaedic Postoperative Ward
313 Mettupalayam road
Coimbatore
Tamilnadu.
Coimbatore
TAMIL NADU |
9894947781
vinothvelusamy59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (3) ICD-10 Condition: M138||Other specified arthritis, (4) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nerve Block Comparison |
Quadratus Lumborum Block with Suprainguinal Fascia Iliaca Block in First 24Hours PostoperativePeriod. |
| Intervention |
Quality of Analgesia |
Less Opioid Requirement in the
Postoperative Period of First 24Hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Osteoarthritis Hip
Rheumatoid Arthritis Hip
Avascular Necrosis of Hip
Traumatic Arthritis Hip
ASA Class One Two and Three
Patient Oriented to Give Consent.
|
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
ASA FOUR AND FIVE
PATIENTS WITH BLEEDING DIATHESIS
CHRONIC USE OF OPIOIDS
PATIENT NOT ABLE TO GIVE INFORMED CONSENT
KNOWN HYPERSENSITIVITY TO LOCAL ANAESTHETIC DRUGS
PATIENTS LESS THAN 18YRS AND MORE THAN 65YRS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
Quality of Analgesia assessed by VAS Score at 30mins,1hour,2hours,3hours,4hours,5hours,6hours,8th hour,10th hour,12th hour,18th hour,24th hour after Nerve Block Administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
After Nerve Block Administration at 30mins,1Hour,2hours,3hours,4hours,5hours,6hours,8th hour,10th hour,12th hour,18th hour,24Hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/04/2024 |
| 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="6"
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
|
HIP JOINT IS ONE OF THE RICHLY INNERVATED JOINTS AND COMPLETE ANALGESIA IN HIP SURGERIES CAN BE ACHIEVED ONLY IF WE TARGET BOTH THE ANTERIOR AS WELL AS POSTERIOR COMPONENTS OF NERVE SUPPLY REGIONAL ANALGESIA TECHNIQUES ARE POPULAR IN HIP SURGERIES DUE TO THEIR OPIOID SPARING EFFECTS AND LESS ADVERSE EFFECTS |