| CTRI Number |
CTRI/2023/10/058647 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| 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 STUDY ON ULTRASOUND GUIDED CONTINUOUS SUPRAINGUINAL FASCIA BLOCK
INFUSION AND CONTINUOUS FEMORAL NERVE BLOCK INFUSION FOR POST SURGERY PAIN IN PATIENTS UNDERGOING HIP REPLACEMENT DONE UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A randomised controlled, Double blinded study on Ultrasound guided Continuous Suprainguinal Fascia Iliaca block infusion vs Continuous Femoral Nerve block infusion for postoperative analgesia in patients undergoing Total Hip Arthroplasty done under General Anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TEENA N S |
| Designation |
DNB ANAESTHESIOLOGY TRAINEE |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIA ,SRM INSTITUES FOR MEDICAL SCIENCE
N0.1 JAWAHARLAL NEHRU ROAD
VADAPALANI
CHENNAI
Chennai
TAMIL NADU
600026
India |
| Phone |
7010058736 |
| Fax |
|
| Email |
teenasubramani97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MADHAVAN M |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIA ,SRM INSTITUES FOR MEDICAL SCIENCE
N0.1 JAWAHARLAL NEHRU ROAD
VADAPALANI
CHENNAI
Chennai
TAMIL NADU
600026
India |
| Phone |
9381513969 |
| Fax |
|
| Email |
maddysuxa2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MADHAVAN M |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIA,SRM INSTITUES FOR MEDICAL SCIENCE
N0.1 JAWAHARLAL NEHRU ROAD
VADAPALANI
CHENNAI
TAMIL NADU
600026
India |
| Phone |
9381513969 |
| Fax |
|
| Email |
maddysuxa2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM INSTITUTES FOR MEDICAL SCIENCE
NO.1 JAWAHARLAL NEHRU ROAD,
VADAPALANI
CHENNAI,600026 |
|
|
Primary Sponsor
|
| Name |
SRM INSTITUTES FOR MEDICAL SCIENCE |
| Address |
SRM INSTITUES FOR MEDICAL SCIENCE
N0.1 JAWAHARLAL NEHRU ROAD
VADAPALANI
CHENNAI 600028 |
| 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 MADHAVAN M |
SRM INSTITUITES FOR MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIA ,NO 1 JAWAHARLAL NEHRU ROAD
VADAPALANI
CHENNAI-600026
Chennai
TAMIL NADU |
9381513969
maddysuxa2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIMS INSTITUTIONAL ETHICS 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 |
| Comparator Agent |
NERVE BLOCK TECHNIQUE using drug 0.2% ropivacaine |
SUPRAINGUINAL FASCIA ILIACA BLOCK VS FEMORAL NERVE BLOCK using 0.2% ropivacaine for 48 hours postoperatively |
| Intervention |
NERVE BLOCK TECHNIQUE using 0.2% ropivacaine |
SUPRAINGUINAL FASCIA ILIACA BLOCK VS FEMORAL NERVE BLOCK using 0.2% ropivacaine for 48 hours postoperatively in total hip Arthroplasty patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA GRADE 1 AND 2
2 ALL GENDERS
3 PATIENT ADMITTED FOR TOTAL HIP ARTHROPLASTY
4 PATIENT WILLING TO PARTICIPATE IN THIS STUDY
5 AGE 20-75 YEARS |
|
| ExclusionCriteria |
| Details |
1 ASA GRADE 3 AND 4
2 AGE<20 YEARS AND >75 YEARS
3 PREGNANT AND LACTATING MOTHERS
4 OBESE INDIVIDUALS WITH BMI MORE THAN OR EQUAL TO 30
5 PATIENTS PARTICIPATING IN ANY OTHER CLINICAL STUDIES
6 PATIENTS ALLERGIC TO LOCAL ANAESTHETICS AND ANY OTHER DRUGS USED IN THIS STUDY
7 PATIENT NOT WILLING TO PARTICIPATE IN THIS STUDY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE POSTOPERATIVE ANALGESIA IN GROUP A AND GROUP B |
48HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
15/11/2023 |
| 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
|
I about to do a study comparing continuous infusion of suprainguinal fascia iliaca block and femoral nerve block for postoperative pain using Visual analog scale score ,quadriceps muscle strength using MRC grading and rescue analgesic requirement tramadol 1mg/kg in patients undergoing total hip arthroplasty done under general anaesthesia by ultrasound guided technique till 48 hours postoperatively. |