| CTRI Number |
CTRI/2025/01/079617 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided two different blocks (Suprainguinal Fascia
Iliaca Compartment block and
Pericapsular nerve group block)
before positioning of patients for spinal
anaesthesia in hip surgeries. |
|
Scientific Title of Study
|
Ultrasound guided Suprainguinal Fascia Iliaca Compartment block (FICB) versus Pericapsular nerve group block (PENG) before positioning of patients for spinal anaesthesia in hip surgeries -A Randomised control study (Non inferiority study design )
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARVATHY PADMENDU |
| Designation |
Postgraduate student |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8848111858 |
| Fax |
|
| Email |
padmendu97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik Jain M |
| Designation |
Associate Proffessor |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9845513713 |
| Fax |
|
| Email |
karthikjain@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik Jain M |
| Designation |
Associate Proffessor |
| Affiliation |
St johns medical college hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9845513713 |
| Fax |
|
| Email |
karthikjain@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college and hospital, Koramangala, Bangalore-560034 |
|
|
Primary Sponsor
|
| Name |
Dr Parvathy Padmendu Department of Anesthesiology |
| Address |
Department of Anaesthesiology ,Second Floor OT Complex,St.
Johns Medical College and Hospital, Bangalore-560034 |
| 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 Parvathy Padmendu |
St.Johns medical college and hospital |
Department of Anaesthesiology ,Second Floor OT Complex,St.
Johns Medical College and Hospital,Koramangala, Bangalore,Karnataka
Bangalore
KARNATAKA |
8848111858
padmendu97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,St Johns Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FASCIA ILIACA BLOCK |
Dose-20ml of 1% xylocaine+adrenaline-under ultrasound guidence echogenic needle will be inserted cephalad to inguinal ligament from lateral to medial through sartorius muscle and fascia illiaca .A successful seperation of fascia illiaca from iliacus muscle will be observed .VAS score calculated for a period of 2 hours Post block |
| Comparator Agent |
PENG BLOCK |
Dose-20ml of 1% xylocaine+adrenaline-under ultrasound guidance,using in plane technique,injected between psoas tendon and pelvic rim,VAS score calculated for a period of 2 hours post block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex, aged between 18-80 years
2.Patients belonging to ASA Physical Status 1,2,3
3.Patients undergoing surgeries for hip fractures
|
|
| ExclusionCriteria |
| Details |
1.Patients with coagulopathies or on anticoagulants
2.Patients with known allergy to local anaesthetic agents
3.Infection at the procedure site
4.Patients with peripheral sensorineural deficit
5.Patients with spinal deformities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare analgesic efficacy of Pericapsular Nerve Group Block (PENG) versus Suprainguinal Fascia illiaca compartment block(FICB) among patients with hip fractures for pain relief during positioning for spinal anaesthesia using VAS scores.
|
A 10CM VAS score is recorded immediately after the block before and after positioning for spinal anaesthesia and vitals and complications are
observed for a period of 5 minutes,30 min, 1 hour,1 and half hour and 2 hrs intraoperatively and 5 min,30min, 1 hour,2 hour,6 hour and 24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the comfort of anaesthetist while giving spinal anaesthesia by quality of position obtained for spinal anaesthesia.
2.To describe the proportion of various complications.
|
A 10 cm VAS score is recorded before and after positioning for spinal anaesthesia and vitals and complications are observed 5 min,30min,1 hour ,1 and half hour and for a period of 2 hrs intraoperatively and
5 min, 30min, 1 hour,2 hour,6 hour and 24 hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/02/2025 |
| 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="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
|
Hip fractures are very painful condition perioperatively .Hip fractures are also disabling and painful that any movement during transfer or during any procedures causes excruciating pain. Conventionally hip surgeries are done under spinal anaesthesia and pain management is always a challenging task for all anaesthetists. Severe pain also makes positioning of patients for spinal anaesthesia difficult. Regional blocks like Pericapsular nerve group block , Fascia iliaca compartment block and Femoral nerve block provide good analgesia for positioning of patients during spinal anesthesia.Spinal anaesthesia is the preferred choice of anaesthesia in patients with hip fractures. Regional blocks including femoral nerve block ,Fascia iliaca compartment block (FICB),Pericapsular nerve group block(PENG) are routinely given before positioning patients for spinal anaesthesia.Use of ultrasound allows better visualization and increases the success rate of peripheral nerve blocks . We decided to compare the analgesic efficacy of ultrasound guided Suprainguinal Fascia Iliaca compartment block with Pericapsular Neve Group block in positioning of patients for spinal anaesthesia in hip fractures.Patients will be randomly (using shuffled deck of cards- Even means FICB and Odd means PENG block) divided into two groups of 22 each: Group A-Patient receiving Suprainguinal Fascia iliaca compartment block [FICB] .Group B-Patient receiving Pericapsular nerve group block[PENG].All patients will be taught about 10 cm Visual analogue scale preoperatively and it is scored between 0 to 10 (0-no pain,10-worst possible pain). VAS score will be assessed before,during and after placement in sitting position.Patients will be monitored as per standard ASA guidelines. Hemodynamic variables [HR, SPO2, BP, RR] will be evaluated and assessed.After giving block, pain will be assessed by (VAS)Score which will be recorded before, while and after placing the patient in sitting position.Comfort of anaesthetist, will be assessed by asking the anaesthetists about quality of position obtained while giving spinal anaesthesia and will be graded as not satisfactory, satisfactory and good. Patients vitals will be monitored and will be assessed for complications including hematoma, intravascular injuries etc.. |