| CTRI Number |
CTRI/2021/04/033135 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check pain decrease Power after operation between pericapsular Nerve group block alone with combination ofpericapsular Nerve group and lateral femoral cutaneous nerve block ,in patients who will under go hip surgery |
|
Scientific Title of Study
|
Comparison of Peng(pericapsular nerve group) block vs.peng and lfcn( lateral femoral cutaneous nerve ) block in terms of analgesic efficacy in patients undergoing hip 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 |
Dr akhil Kant singh |
| Designation |
Assistant proffesor |
| Affiliation |
All India institute of medical science,Ansari nagar,south Delhi, |
| Address |
Department of anaesthesiology,pain medicine & critical care,room no-5012, teaching blocks,aiims new delhi,Ansari nagar,south Delhi.
South
DELHI
11029
India |
| Phone |
9811702808 |
| Fax |
|
| Email |
dr.akhilsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr akhil Kant singh |
| Designation |
Assistant proffesor |
| Affiliation |
All India institute of medical science,Ansari nagar,south Delhi, |
| Address |
Department of anaesthesiology,pain medicine & critical care,room no-5012, teaching blocks,aiims new delhi,Ansari nagar,south Delhi.
South
DELHI
11029
India |
| Phone |
9811702808 |
| Fax |
|
| Email |
dr.akhilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prayosikta Lenka |
| Designation |
Junior resident |
| Affiliation |
All India institute of medical science,new Delhi |
| Address |
Ab8 floor ,anaesthesia department ,aiims new Delhi
South
DELHI
11029
India |
| Phone |
8457808505 |
| Fax |
|
| Email |
drprayosikta7413@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,pain medicine & critical care,aiims new Delhi. |
|
|
Primary Sponsor
|
| Name |
Dr akhil Kant singh |
| Address |
Department of anaesthesiology,pain medicine & critical care,room no:5012, teaching blocks,all India institute of medical science,Ansari nagar,south Delhi,11029,india |
| 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 akhil Kant Singh |
Aiims new Delhi |
Department of anaesthesiology,pain medicine & critical care ,aiims new Delhi,11029 ,india
South
DELHI |
9811702808
dr.akhilsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee,aiims new Delhi |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Both pericapsular nerve group block and lateral cutaneous femoral nerve block |
After completion of Peng block ,needle will be withdrawn to plane between fascia iliaca and fascia lata and 20 ml (0.25%) bupivacaine will be injected |
| Intervention |
Pericapsular nerve group ( Peng) block . |
Peng block will be carried out by administering Bupivacaine 20 ml,0.25 % ,will be given by spinal needle in between anterior inferior ileac spine and superior pubic ramus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 and 2 ,patiens under going hip surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1) Patients refusal to participate in study
2) Patients with coagulopathy,sepsis
3) Patients allergics to local anaesthestic agents
4) Patients with pre exiting neuropathies
5) Patients with local infection around needle site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total iv opioid consumption in first 24 hour following hip surgery |
Total iv opioid consumption in first 24 hour following hip surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time to first dose of rescue bolous iv fentanyl in post operative period
2)Opioid dosage in 1st 6 hours,6-12 hrs,12-24 hours following surgery
3) Numerical rating scale at,1,2,4,6,12 and 24 hour after block administration,at rest and movement (15 degree leg elevation)
4) sedation score |
With in 24 hour following surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2021 |
| 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="2"
Months="0"
Days="5" |
|
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
|
Various hip surgeries are asdassocia with severe post operative pain .systemic opioids which are used in analgesia,have disadvantage of nausea,vomi vomiting,pruritus,respira resp depression,and urinary retention.Various regional anaesthesia techniques described for analgesia for post operative period are 1.Fascia iliaca block2.Obturator block 3. Three in one block but a recent novel technique has been introduced called pericapsular nerve group block which targets bulk of nerve supply to anterior hip capsule and it provides coverage of only sensory nerve sparing motor blockade of quadriceps which is a known complications of fascia iliaca and femoral block. Peng block technique involves deposition of local anaesthestic in musculofascial planes between psoas muscle and superior pubic ramus.It targets articular branch of femoral nerve,obtu obtur nerve,accesory obturator nerve,because these nerves are constantly found between anterior inferior iliac spine and iliopubic eminence in superior pubic ramus.Despite this procedure few patients still cimplaco pain along latera portion of thigh due to dermatomical distributions of lateral femoral cutaneous nerve . So we ll consider 2 groups of patients. Group A: peng block Group B : Peng with lfcn block We hypothesize that combined Peng and lfcn block reduce more post operative pain and opioid consumption than Peng block alone. The patient ll evaluate for 24 hour following surgery |