| CTRI Number |
CTRI/2020/02/023640 [Registered on: 28/02/2020] Trial Registered Prospectively |
| Last Modified On: |
19/02/2020 |
| 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
|
Study to compare postoperative analgesic efficacy between Fascia Iliaca block and PENG block |
|
Scientific Title of Study
|
A Randomised Controlled Trial to assess the postoperative analgesic efficacy of Fascia Iiliaca Block Versus Pericapsular Nerve Group (PENG)Block in patients undergoing hip fixation surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddharth Thakur |
| Designation |
PG First Year M.D.Anaesthesiology |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
de;partment of anaesthesiology
Shaheed Bhagat Singh Marg
Lady Hardinge Medical College
de;partment of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi -110001
Central
DELHI
110007
India |
| Phone |
9717136557 |
| Fax |
|
| Email |
siddgarastdujy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajai Kumar |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001
Central
DELHI
110001
India |
| Phone |
9868848814 |
| Fax |
|
| Email |
drajaikumar11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajai Kumar |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001
Central
DELHI
110001
India |
| Phone |
9868848814 |
| Fax |
|
| Email |
drajaikumar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001
|
| Type of Sponsor |
Government medical college |
|
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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 |
| Siddharth Thakur |
Lady Hardinge Medical College |
Lady Hardinge Medical College
department of anaesthesiology
Shaheed Bhagat Singh Marg
New Delhi - 110001
Central
DELHI |
9717136557
siddgarastdujy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M955||Acquired deformity of pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascia Iliaca Block |
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until its origin to anterior superior iliac spine. The shadow of the bony of iliac crest &iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 20ml of 0.25 PERCENT bupivacaine will be injected |
| Intervention |
Pericapsular Nerve Group (PENG) Block |
the patient is in the supine position , a curvilinear low frequency ultrasound probe will initially be placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees . In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, the pectineus muscle will be visualized . An 18G, Tuohy’s needle will be inserted from lateral to medial in an in-plane approach to place the needle tip between the psoas tendon anteriorly and pubic ramus posteriorly.After careful confirmation of the needle positioning using 0.9 percent Saline injection, and negative aspiration 20ml of 0.25 percent bupivacaine will be injected. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. AGE> 18 Years
2. Patients planned for hip fixation surgery under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal
2. Any known drug allergies.
3. Contraindication to nerve block like coagulopathy, bleeding diathesis and local infections.
|
|
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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. Mean NRS Score at 0,4,8,12, 24 hours postoperatively in patients at rest and in movement |
1. 0,4,8,12,24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in NRS score while positioning for spinal anaesthesia
2. Mean dosage of 24 hours postoperative analgesic requirements
3. Proportion of catheter related and drug related complications.
|
24 hour postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/02/2020 |
| 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
|
Results will be published in a scientific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Hip fracture is a common orthopedic emergency in the elderly and is associated with significant morbidity and mortality, surgical reductions and fixations are the definitive treatments in most patients. Adequate pain relief is essential in the postoperative period . Initially intravenous patient controlled analgesia and epidural analgesia were used . these have been replaced by various peripheral nerve blockade techniques ; these include lumbar plexus block , psoas compartment block , femoral nerve block and so on . Recently fascia iliaca block and (Pericapsular Nerve Group ) PENG block have been proposed for the same ,but there has been no comparative study regarding the two blocks . These peripheral nerve blocks have been found to be associated with reduced motor blockade , early ambulatory outcomes , adequate analgesia and decreased requirement of opioids .
This study is a randomized controlled trial to assess the efficacy of fascia iliaca and PENG block in the postoperative period. The selection of the patients for the block will be done by computer generated random table and both the blocks will be given preoperatively and catheter will be placed at the site of the block and infusion pumps containing the drugs will be attached to the catheter. The surgery will be done under spinal anaesthesia and the catheter will be placed for 48 hours postoperative duration.
Following observations will be made
1. Mean NRS ( Numerical Rating Scale) score at 0 , 4,8,12, and 24 hours postoperatively 2. Change in NRS score while positiong for spinal anaesthesia 3. Mean dosage of 24 hours postopearive analgesic requirement 4. Proportion of catheter and drug related complications
Data will be collected and compiled in an excel sheet and will be analyzed statistically .
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