| CTRI Number |
CTRI/2021/07/034648 [Registered on: 07/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two different types of nerve group block for reducing pain during positioning for spinal anaesthesia in patients of fracture thigh bone |
|
Scientific Title of Study
|
Comparative evaluation of Pericapsular nerve group Block with fascia iliaca Compartment block for Reducing pain associated With positioning for Subarachnoid block in Patients undergoing proximal Femur fracture 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 Tapesh Maurya |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Ground Floor, Main OT Building, Vardhman Mahavir Medical college and Safdarjung Hospital, New Delhi
C/o A P Bansal
214 B Gautam nagar New Delhi
New Delhi 110029
South
DELHI
110029
India |
| Phone |
9897309789 |
| Fax |
|
| Email |
tapesh.maurya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Associate Professor Anaesthesiology |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Ground Floor, Main OT Building, Vardhman Mahavir Medical college and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Guria |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Ground Floor, Main OT Building, Vardhman Mahavir Medical college and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, VMMC AND SJH, DELHI |
|
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Primary Sponsor
|
| Name |
VMMC AND SJH |
| Address |
SOUTH DELHI- 110029 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| DR TAPESH MAURYA |
C/O A.P BANSAL 214-B, NEW DELHI-110049 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Tapesh Maurya |
Safdarjung Hospital |
Department of Anaesthesia and Intensive Care,Ground Floor, Main OT Building
South
DELHI |
9897309789
tapesh.maurya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: S720||Fracture of head and neck of femur, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascia Iliaca Compartment Block |
Group F will receive ultrasound guided FICB block(In supine position, under all aseptic technique 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 it’s origin to anterior superior iliac spine. The shadow of the bony of iliac crest and 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, 30 mL of 0.25% of levobupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.) and 20 minutes later they will be placed in sitting position for the performance of subarachnoid block.Visual Analogue Scale (VAS) will be assessed and noted using a standard 10 cm VAS with 0 corresponding to no pain and 10 designating the worst possible pain before the block, 20 minutes after the block and during positioning for subarachnoid block (Approx . 30 min. after block). |
| Intervention |
Pericapsular nerve group block |
Group P will be receiving ultrasound guided PENG block(A curvilinear ultrasound probe will be initially placed in the transverse plane over the Anterior inferior iliac spine 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 and pectineus muscle will be observed. A 22-gauge, 80-mm sonoplex needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.30 ml of levobupivacaine 0.25% will be injected in 5-mL increments) and 20 minutes later they will be placed in sitting position for the performance of subarachnoid block.Visual Analogue Scale (VAS) will be assessed and noted using a standard 10 cm VAS with 0 corresponding to no pain and 10 designating the worst possible pain before the block, 20 minutes after the block and during positioning for subarachnoid block (Approx . 30 min. after block). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA-I and II Physical status scheduled for proximal femur fracture surgery under subarachnoid block |
|
| ExclusionCriteria |
| Details |
Patients who can sit comfortably/having contraindication for subarachnoid block/known allergy to local anesthetics/ preexisting peripheral neuropathies/receiving chronic analgesic therapy
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of Pericapsular nerve group block(PENG) with Fascia iliaca compartment block for reducing pain during positioning for subarachnoid block using visual analogue scale(VAS) pain score |
At the time of positioning for subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Spinal anaesthesia performance time
2.Performer satisfaction with positioning
3.Duration of analgesia by measuring time taken to first rescue analgesia demand
4. Patient satisfaction score |
0hr, 4hrs, 8hrs, 12hrs and 24hrs |
|
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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)
|
15/07/2021 |
| 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="1"
Months="6"
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
|
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Brief Summary
|
Positioning for spinal anaesthesia can be extremely painful and cause sympathetic activation and major distress that may compromise high risk cardiac patients. Effective management of pain is important for patient comfort and easier performance of central neuraxial blockade. Various blocks have been used like classical femoral nerve blocks, 3 in 1 block and fascia iliaca compartment block to serve this purpose. But none of the blocks covers obturator nerve in the procedure. Pericapsular nerve group block (PENG) is a recently used block for the same purpose with additional advantage of covering the articular branches of hip. This study is based on the hypothesis that PENG block should be more effective in reducing pain associated with positioning for spinal anaesthesia in paitents undergoing surgery for proximal femur fracture as compared to fascia iliaca compartment block. |