| CTRI Number |
CTRI/2024/12/078608 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| 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
|
Comparison of ultrasound guided two nerve blocks in hip region for hip surgeries- Prospective randomised control trail |
|
Scientific Title of Study
|
Comparison of ultrasound guided anterior quadratus lumborum block versus combined pericapsular nerve group block with lateral femoral cutaneous nerve block in hip surgeries-Prospective randomised control trail |
| 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 Mohammed Arfak H |
| Designation |
PG student |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
natesan nagar
alapakkam
chennai 116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9952763355 |
| Fax |
|
| Email |
mohammedarfak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rajesh Kumar Kodali V |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Department of Anesthesia,
Flat No 30,F block,
SRMC Staff quarters,
Porur,
Chennai 60016
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9962398266 |
| Fax |
|
| Email |
Vrajesh.kodali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Rajesh Kumar Kodali V |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Department of Anesthesia,
Flat No 30,F block,
SRMC Staff quarters,
Porur,
Chennai 60016
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9962398266 |
| Fax |
|
| Email |
Vrajesh.kodali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,Porur,Chennai 600 116,Tamil nadu,India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No 1,Sri Ramachandra Nagar,
Chennai 60016,
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 Mohammed Arfak H |
Sri Ramachandra Institute of Higher Education and Research Institute |
No1,Ramachandra Nagar,Sri Ramachandra nagar,Chennai
Chennai
TAMIL NADU |
09952763355
mohammedarfak96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee (for Medical PG Students),SRIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided anterior quadratus lumborum block |
Patient will receive ultrasound guided anterior quadratus lumborum block with 25ml of 0.25% ropivacaine and 0.1mg/kg of dexamethasone before spinal anesthesia |
| Comparator Agent |
Ultrasound guided pericapsular nerve group block with lateral femoral cutaneous nerve block |
Patient will receive ultrasound guided pericapsular nerve group block with lateral femoral cutaneous nerve block with 22ml pericapsular nerve group block combined with 3ml of lateral femoral cutaneous nerve block with 0.25% ropivacaine and 0.1mg/kg of dexamethasone before spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist (ASA) I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal for participation
Known coagulation disorder
Allergies to study drugs
Chronic pain
Morbidly obese
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of rescue analgesia consumption |
0 hour,2 hours,4 hours,8 hours,12 hours,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative pain intensity(NRS scale)
Duration of analgesia
Time for initial rescue analgesia
Hemodynamic data such as heart rate, systolic BP, diastolic BP, mean arterial pressure, saturation of oxygen
|
30 minutes,1 hour,2 hours,4 hours,8 hours,12 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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 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
|
Patient who fit in to inclusion criteria will be enrolled into the study after getting written informed consent from the patient. All patient’s assessment will be done on the previous day and nil per oral orders will be given as per department protocol.Baseline blood pressure and heart rate will be recorded before shifting to operating room.After shifting to operating room electrocardiography, non invasive blood pressure and oxygen saturation will be connected. A total of 60 patients of ASA I and II(aged 20-60 years) undergoing hip surgeries will be randomly allocated into two groups of 30 each.Group 1 will receive ultrasound guided anterior quadratus lumborum block with 25 ml of 0.25% ropivacaine with 0.1mg/kg of dexamethasone and Group 2 will receive combined pericapsular nerve group block (22ml) with lateral femoral cutaneous nerve block (3ml) with 0.25% ropivacaine with 0.1 mg/kg of dexamethasone before spinal anesthesia.Intraoperatively heart rate, non invasive blood pressure and oxygen saturation will be monitored every 3 minutes for first 15 minutes and at 5 minutes for next 15 minutes. |