| CTRI Number |
CTRI/2022/06/043027 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
03/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of FICB and PENG block under USG guidance for ease of positioning the patients for administrating spinal anaesthesia and post operative pain relief |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF ULTRASOUND GUIDED FASCIA ILIACA BLOCK AND PERICAPSULAR NERVE GROUP [PENG] FOR POSITIONING AND POSTOPERATIVE ANALGESIA PRIOR TO SPINAL ANAESTHESIA FOR 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 |
Dr OM SHIVA S T |
| Designation |
Post Graduate |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
Dept. of Anaesthesia,
OT complex, 1st floor, Dr. B. R. Ambedkar medical College and hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
7353534654 |
| Fax |
|
| Email |
omshivast@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANTOSH KUMAR |
| Designation |
Associate professor |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
Dept. of Anaesthesia,
OT complex, 1st floor, Dr. B. R. Ambedkar medical College and hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr OM SHIVA S T |
| Designation |
Post Graduate |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
Dept. of Anaesthesia,
OT complex, 1st floor, Dr. B. R. Ambedkar medical College and hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
7353534654 |
| Fax |
|
| Email |
omshivast@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B. R. Ambedkar medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Kumar |
| Address |
OT complex, 1st floor, Dr. B. R. Ambedkar medical College and hospital, KG Halli, Bengaluru |
| 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 Santosh Kumar |
Dr. B. R. Ambedkar medical College and hospital |
OT complex, 1st floor, Dr. B. R. Ambedkar medical College and hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA |
9845785715
drsantoshkumarcc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee Dr. B. R. Ambedkar medical College and 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 |
| Intervention |
Fascia Iliaca block |
Fascia Iliaca block with injection 0.25% Bupivacaine 25ml, by ultrasound guided landmarks in the patients scheduled for hip fracture surgeries |
| Comparator Agent |
Pericapsular Nerve group Block |
Pericapsular Nerve group Block (PENG) with 0.25% Bupivacaine 25ml, by ultrasound guided landmarks in the patients scheduled for hip fracture surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for fracture hip surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Pregnancy and lactating mothers.
Altered coagulation profile or bleeding diasthesis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scoring and numerical rating scale of pain of less than or equal to 3 |
Visual analogue scoring and numerical rating scale of pain of less than or equal to 3 at 15 minutes, 30 minutes, one hour, 2 hour, 4th hour, 8th hour, 12th hour, 18th hour and 24th hour post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pain in visual analogue scoring and numerical rating scale |
Post-operative for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/06/2022 |
| 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
|
|
Brief Summary
|
Lower limb fractures like fracture femur pose a challenge to anesthesiologists in positioning the patients for spinal anesthesia. It is often difficult because of excruciating pain.
This also presents difficulty in administration of spinal anesthesia because of inappropriate position of the patient. Hence, there is a need to provide good pain relief to such patients in order to facilitate appropriate positioning for spinal anesthesia. This also provides comfort to the patient and reduces stress response because of pain relief.
Advantages of fascia iliaca compartment block (FICB) and Pericapsular Nerve group Block (PENG) are that, it is inexpensive and can be easily administered using anatomical landmarks to provide perioperative analgesia in patients with fracture femur. Local anesthetic agent like bupivacaine has been introduced as it is potent and long acting which offers prolonged anesthesia with post operative analgesia.
Therefore, ultrasound quided FICB or PENG block is administered as it has better accuracy compared to landmark technique. FICB or PENG block is administered with Bupivacaine. VAS and NRS scores are noted before blocks and during positioning the patient for spinal anaesthesia. |