CTRI Number |
CTRI/2021/09/036787 [Registered on: 23/09/2021] Trial Registered Prospectively |
Last Modified On: |
24/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To study the effect of two regional anesthesia techniques for adequate pain control after surgeries around hip joint |
Scientific Title of Study
|
Comparison of analgesic efficacy of supra-Inguinal fascia iliaca compartment block (S-FICB) and pericapsular nerve group (PENG) block in patients undergoing hip surgery: A prospective randomized controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sadik Mohammed |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences, Jodhpur |
Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.
Jodhpur RAJASTHAN 342005 India |
Phone |
9414849733 |
Fax |
|
Email |
drmsadik@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sadik Mohammed |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences, Jodhpur |
Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.
RAJASTHAN 342005 India |
Phone |
9414849733 |
Fax |
|
Email |
drmsadik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Subham Das |
Designation |
PG Student |
Affiliation |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.
Jodhpur RAJASTHAN 342005 India |
Phone |
9531127885 |
Fax |
|
Email |
sdasqwert@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS Jodhpur |
Address |
All India institute of medical sciences (AIIMS), HI Area Phase II, Basni, Jodhpur, Rajasthan 342005 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Sadik Mohammed |
AIIMS, Jodhpur |
Department of Anaesthesiology and Critical Care, 3rd Floor, DnT Block, AIIMS, Phase II, Basani Industrial Area, Jodhpur.
Jodhpur RAJASTHAN |
0291-2740741
drmsadik@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Pericapsular Nerve Group Block |
Ultrasound guided deposition of 20 mL bupivacaine 0.5% with epinephrine 5 mcg/mL between psoas tendon and pubic ramus. |
Comparator Agent |
Supra-inguinal fascia ilica compartment block |
Ultrasound guided deposition of 40 mL bupivacaine 0.5% with epinephrine 5 mcg/mL above iliacus muscle. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Belonging to American Society of Anesthesiologists Physical Status 1-3 and Scheduled for elective unilateral total hip replacement surgery.
|
|
ExclusionCriteria |
Details |
1. Known hypersensitivity to any of the drugs used in the study.
2. Patient having infection at the site of block.
3. Patients with coagulopathy or on anticoagulation therapy.
4. Patients with untreated psychiatric illness.
5. Patients with known cardiac, hepatic or kidney diseases.
6. Opioid Dependency
7. Pre-existing neurologic or anatomic deficits in the lower extremities
8. Prior surgery in the corresponding side of the inguinal or suprainguinal area
9. Chronic pain syndromes requiring opioid intake at home
10. Pregnancy |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Post-operative pain relief assessed by Numeric Rating Scale (NRS) at fixed time interval |
First 24 postoperative hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Motor Blockade at fixed time interval
2. The time of first rescue analgesic requirement.
3. Total amount of analgesia consumed during 24-hours.
4. Duration to perform block.
5. Patient’s satisfaction for the mode of analgesia.
6. Periprocedural complication.
|
First 24 postoperative hours |
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/10/2021 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
31/08/2023 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On personal request through mail at drmsadik@gmail.com
- For how long will this data be available start date provided 07-04-2023 and end date provided 31-03-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Pre-anaesthetic evaluation will be
done for all the patients, a day before surgery. All patients will be
thoroughly explained about the procedure. They will also be made well
conversant about the Numeric Rating Scale (NRS) ranged from 0 to 10 (0 = no
pain and 10 = worst imaginable pain). The standard instruction of fasting will
be given to all patients (2 hours for clear liquids and 6 hours for semisolid
and solid food).
On arrival of the patient in
preoperative holding area, patient identification, fasting status, consent, and
PAC will be confirmed. In the procedure room, standard ASA monitors like
electrocardiogram (ECG), non-invasive blood pressure (NIBP) pulse oximetry will
be attached and baseline vitals will be recorded. A peripheral intravenous
cannula will be secured in ipsilateral upper limb and intravenous fluids will
be started. All patients will receive combined spinal epidural (CSE). Epidural
space will be identified using loss of resistance to saline subarachnoid block
will be performed using needle through needle technique with bupivacaine 0.5%
heavy 15 mg. Epidural catheter will be secured and a test dose (3 mL of
lignocaine 1.5% with 5 mcg/mL epinephrine) will be administered through the
catheter. Following CSE, one of the intervention techniques as per
randomization will be performed. Following the
block patients will undergo the scheduled surgery. During the surgery vitals
[heart rate (HR), mean arterial pressure (MAP), oxygen saturation (SpO2)
and temperature] will be recorded. No further analgesics will be administered
during the surgery. After completion of surgical procedure, patients will be
shifted to PACU. Postoperative analgesia will be assessed
using NRS immediately after receiving the patient in the PACU and thereafter at
1-hour, 3-hours, 6-hours, 12-hours, 18-hours and at 24-hours. On recording of
NRS ≥4 or on patient demand rescue analgesia (10 mL 0.2% ropivacaine) through
epidural catheter will be administered and time to rescue analgesia will be
recorded. Total epidural boluses during the observation period will also be
recorded. The motor blockade will be assessed at
predefined time interval by testing the quadriceps motor function with the
patient supine and with the hip and knee flexed at 45º and 90º, respectively.
The patient will be asked to extend the knee first against gravity and then
against resistance. Quadriceps strength will be graded according to a 3-point
scale: normal strength = 0 point (extension against resistance); paresis = 1
point (extension against gravity but not against resistance); and paralysis = 2
points (no extension). Patient satisfaction will be recorded on a
four-point Likert’s scale as 1- excellent; 2- good; 3- fair and 4- poor. Block performance time defined as time
interval between putting the ultrasound probe and completion of LA agent. Periprocedural
complication like vascular puncture, paresthesia, systemic LA toxicity etc will
be recorded. |