| CTRI Number |
CTRI/2023/05/052200 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECT OF ROPIVACAINE & ROPIVACAINE WITH MAGNESIUM SULPHATE AS ADJUVANT IN USG GUIDED FASCIA ILIACA BLOCK FOR PATIENTS UNDERGOING PROXIMAL FEMUR FRACTURE SURGERY |
|
Scientific Title of Study
|
Efficacy of Ropivacaine verses Ropivacaine with Magnesium Sulphate as Adjuvant in usg Guided Fascia Iliaca Block in Proximal Femur Fracture Surgery- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KASTURI DASH |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,KALINGA INSTITUTE OF MEDICAL SCIENCE,PATIA BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9437007099 |
| Fax |
|
| Email |
titlidash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LINGARAJ SAHU |
| Designation |
PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KALINGA INSTITUTE OF MEDICAL SCIENCE PATIA BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
8249413544 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
KASTURI DASH |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,KALINGA INSTITUTE OF MEDICAL SCIENCE,PATIA BHUBHANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9437007099 |
| Fax |
|
| Email |
titlidash@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KASTURI DASH |
| Address |
KALINGA INSTITUTE OF MEDICAL SCIENCE,PATIA,BHUBANESWAR |
| Type of Sponsor |
Other [ ] |
|
|
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 |
| KASTURI DASH |
KALINGA INSTITUTE OF MEDICAL SCIENCE |
THIRD FLOOR ,OT COMPLEX,DEPARTMENT OF ANAESTHESIA,KALINGA INSTITUTE OF MEDICAL SCIENCE,PATIA,BHUBANESWAR
Khordha
ORISSA |
9437007099
titlidash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROPIVACAINE |
FASCIA ILIACA BLOCK IN POST OPERATIVE PERIOD AND VAS SCORE WILL BE MONITORED EVERY TWO HOURLY TILL 24 HOURS TO BE INTERVENED FOR 1YEAR |
| Intervention |
ROPIVACAINE WITH MAGNESIUM SULPHATE |
FASCIA ILIACA BLOCK IN POST OPERATIVE PERIOD AND VAS SCORE WILL BE MONITORED EVERY TWO HOURLY TILL 24 HOURS TO BE INTERVENED FOR 1YEAR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.AGE >18YEARS
2.PATIENTS POSTED FOR PROXIMAL FEMUR SURGERY |
|
| ExclusionCriteria |
| Details |
1.ALLERGY
2.PATIENT WITH CHRONIC PAIN SYNDROME
3.ANALGESIC ABUSE
4.ADDICTION TO ALCOHOL/OPIODS
5.COAGULOPATHY
6.INFECTION/SEPSIS AT SITE OF INJECTION
7.SEVERE RENAL FAILURE
8.MYASTHENIA GRAVIS
9.PULMONARY EDEMA
10.HEART BLOCK |
|
|
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 |
| 1.TIME REQUIRED FOR FIRST ANALGESIC DEMAND |
FIRST POST OPERATIVE DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/05/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ROPIVACAINE IS A LONG ACTING LOCAL ANAESTHETIC WITH LESS CARDIOTOXIC AND NEUROTOXIC SIDE EFFECTS AND SPARES THE MOTOR BLOCK AND INCREASES DURATION OF SENSORY BLOCK.SO ADDING ADJUVANT LIKE MAGNESIUM SULPHATE BEING FASTER IN ACTION MAY PRODUCE DENSER BLOCK AND PROLONG THE DURATION OF ANALGESIA |