| CTRI Number |
CTRI/2024/05/067378 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| 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
|
Comparative study of machine guided two nerve blocks for positioning during spinal anaesthesia in lower limb fractures |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF ULTRASOUND GUIDED PERICAPSULAR NERVE GROUP BLOCK (PENG) VERSES FEMORAL NERVE BLOCK (FNB) FOR POSITIONING DURING SPINAL ANESTHESIA IN PROXIMAL FEMUR FRACTURES |
| Trial Acronym |
PENG FNB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VIVEK KUMAR |
| Designation |
PRIMARY DNB RESIDENT |
| Affiliation |
Bokaro General Hospital Bokaro |
| Address |
ROOM NO 07 DNB HOSTEL BOKARO GENERAL HOSPITAL SECTOR 4 BOKARO JHARKHAND
Bokaro
JHARKHAND
827004
India |
| Phone |
9955594660 |
| Fax |
|
| Email |
vivekkumar4494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Raj |
| Designation |
Chief Consultant |
| Affiliation |
Bokaro General Hospital |
| Address |
Bokaro general hospital sector 4 bokaro steel city bokaro
Bokaro
JHARKHAND
827004
India |
| Phone |
8986873079 |
| Fax |
|
| Email |
raj31715@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhat Kumar Dwivedi |
| Designation |
CHIEF CONSULTANT |
| Affiliation |
BOKARO GENERAL HOSPITAL |
| Address |
Bokaro general hospital sector 4 bokaro steel city bokaro
Bokaro
JHARKHAND
827004
India |
| Phone |
8986873083 |
| Fax |
|
| Email |
drprabhatkumardwivedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Bokaro General Hospital, Bokaro, Jharkhand, India, pincode 827004 |
|
|
Primary Sponsor
|
| Name |
BOKARO GENERAL HOSPITAL |
| Address |
Bokaro General Hospital Bokaro Steel City BOKARO JHARKHAND 827004 |
| 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 VIVEK KUMAR |
BOKARO GENERAL HOSPITAL |
Bokaro General Hospital Bokaro Steel City Jharkhand 827004 Bokaro JHARKHAND
Bokaro
JHARKHAND |
9955594660
vivekkumar4494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Bokaro General Hospital |
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 |
Femoral Nerve Block |
For FNB, a high frequency linear USG probe will be placed over inguinal crease. In cross section, femoral vessels and femoral nerve will be identified. Just lateral to the artery and deep to the fascia iliaca , the femoral nerve will be located as a spindle-shaped structure with a honeycomb appearance. 22G block needle will be inserted through fascia iliaca and 20 mL of 0.25% of bupivacaine will be administered after negative aspiration. |
| Intervention |
Pericapsular Nerve Group Block |
For PENG block, a low frequency curvilinear probe will be placed over the anterior superior illiac spine and moved inferiorly to visualise the pubic ramus. Then, iliopectineal eminence will be visualised and the femoral artery and iliopsoas muscle will be identified in centre. the area between iliopectineal eminence and pubic ramus will be our target point. Using 22G block needle using in plane technique, 20mL of 0.25% bupivacaine will be injected after negative aspiration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 & 2 patients.
2.Elective orthopedic surgeries under spinal anesthesia.
3.Patient willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade 3 & 4
3.Local site infection
4.Coagulopathies
5.Polytrauma
6.Allergy to local anesthetics
7.Patient with old fractures (more than 7 days)
8.Difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual assessment score at rest and dynamic |
10 mins after block
20 mins after block
30 mins after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Best angle obtained by the patient during sitting position during spinal anesthesia
Ease of spinal position score
Post op pain score using visual analogue scale
Quadriceps muscle weakness analysed by oxford muscle strength scale at 6 hours |
2 hour
4 hour
6 hour
8 hour
12 hour
24 hour |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
26/05/2024 |
| 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="1"
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
|
Severe pain associated with proximal femur fracture makes spinal anaesthesia in sitting position difficult. Regional blocks such as femoral nerve block (FNB) and fascia iliaca compartment block (FICB) provide good analgesia for positioning. FNB is easy to perform and safe. It has been used for years to provide analgesia for sitting position for performing central neuraxial blockage after hip fractures. However, it can lead to motor weakness. Pericapsular nerve group block (PENG) blocks the articular fibres of femoral nerve, obturator nerve and accessory obturator nerve.supplying anterior hip capsule. So, we aim to compare the analgesic effect of USG guided PENG block and FNB for positional pain during spinal anaesthesia in proximal femur fractures. The minimum sample size required for our study is 54. Randomisation of the sample will be done by computer generated using random number generator to create list of random numbers. GROUP A to get USG guided PENG block 30 mins before spinal anaesthesia. GROUP B to get USG guided FNB 30 mins before spinal anaesthesia. In preoperative room, pain score at rest (VAS-R) and at 15-degree passive limb elevation in supine position will be noted. Under all aseptic and antiseptic precautions, PENG block and FNB block will be given using 20 mL of 0.25% bupivacaine after negative aspiration via 22G block needle. VAS will be assessed at rest (VAS -R and at 15-degree limb elevation (VAS-D) every 10 mins for 30 mins. At 30 mins, patients will be shifted to the operating room. Patient is given a sitting position for spinal anaesthesia and comfort is assessed by ease of spinal position score (EOSP). If VAS is >4, it is considered a block failure. The best angle obtained by the patient during sitting position is also recorded. Post operative pain scoreis assessed by VAS at 2, 4, 6, 8, 12, 24 hrs. Quadriceps muscle weakness will be assessed by Oxford muscle strength scale at 6 hrs. |