| CTRI Number |
CTRI/2023/04/052061 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study to evaluate efficacy of nerve block using local anaesthetic drug (ropivacaine) for positioning to give spinal/epidural anaesthesia |
|
Scientific Title of Study
|
A comparative study between Pericapsular nerve group block and femoral nerve block
using ropivacaine 0.2% 25ml for ease of positioning to central neuraxial block in HIP
surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSaka Dheeraj Kumar |
| Designation |
Senior Resident |
| Affiliation |
ESIC medical college and Hospital |
| Address |
Room no 4001,4th floor,
Dept. of anaesthesia
ESIC Medical college and hospital
Sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
9620132612 |
| Fax |
|
| Email |
dheerajkumar.saka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali krishna D |
| Designation |
Assistant professor |
| Affiliation |
ESIC Medical college and hospital |
| Address |
room no 2003, 2nd floor,
dept. of anaesthesia
ESIC medical college and hospital
sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
9845577447 |
| Fax |
|
| Email |
dmk1887@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Murali krishna D |
| Designation |
Assistant professor |
| Affiliation |
ESIC Medical college and hospital |
| Address |
room no 2003, 2nd floor,
dept. of anaesthesia
ESIC medical college and hospital
sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
9845577447 |
| Fax |
|
| Email |
dmk1887@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and hospital, sanathnagar, hyderabad |
|
|
Primary Sponsor
|
| Name |
ESIC Medical college and hospital |
| Address |
Room no 4001, 4th floor, dept. of anaesthesia, ESIC medical college and hospital, Sanath nagar, hyderabad 50038,Hyderabad, TELANGANA |
| Type of Sponsor |
Government medical college |
|
|
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 Saka Dheeraj kumar |
ESIC Medical college and hospital |
Room no. 4001, 4th floor,
Dept. of Anaesthesia
ESIC Medical college and hospital, sanathnagar
Hyderabad
TELANGANA |
9620132612
dheerajkumar.saka@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 |
Femoral nerve block |
under strict aseptic conditions, ultrasound guided femoral nerve block is given only once with 25ml of 0.2% ropivacaine and will be assessing ease of postioning of patient for central neuraxial block by using pain score and best angle obtained during position of patient upto 30mins |
| Intervention |
Pericapsular nerve group block(PENG block) |
under strict aseptic precautions ultrasound guided pericapsular nerve group block will be given only once with 25ml of 0.2% ropivacaine after negative apsiration for blood, and will be assessing ease of positioning of paient for central neuraxial block by pain score and best angle obtained during position of patient upto 30mins. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
1) Patients of either sex,
2) 50–90 years of age,
3) American Society of Anesthesiologists (ASA) physical grading I–III were included in
the study. |
|
| ExclusionCriteria |
| Details |
1) Exclusion criteria included patient refusal to participate in the study,
2) Presence of any coagulation disorders,
3) Presence of multiple fractures,
4) Any patients with head injury or other injuries, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Efficacy of PENG block
2.Ease of positioning for central neuraxial block |
40mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PURPOSE : A comparative study between Pericapsular nerve group block and Femoral nerve block using 25ml of 0.2% Ropivacaine for ease of positioning to central neuraxial block for Hip surgeries. DESIGN : RANDOMIZED,CONTROLLED TRAIL PARTICIPANT AND CONTROL : Patients undergoing Hip surgeries will be Randomly allocated to one of the two groups based on computer generated random number. INTERVENTION : Site of injection is marked, under strict aseptic precautions and USG guided 25ml Local anaesthetic agent is administered after negative aspiration. Inj. Ropivacaine 0.2% 25ml is administered in incremental dose after negative aspiration for every 5ml using 22G Spinal needle or 10cm stimiplex block needle. Group P will receive 25mls of 0.2% Ropivacaine for pericapsular nerve group block Group F will receive 25mll of 0.2% Ropivacaine for femoral nerve block Vitals and VAS score is monitored from time of injection till position for central neuraxial block. Pain Score and Angle of sitting position to administer central neuraxial block is noted. MAIN OUTCOME MEASURES : Efficacy of Pericapsular nerve group block for positioning of patient for central neuraxial block |