CTRI Number |
CTRI/2023/07/054945 [Registered on: 07/07/2023] Trial Registered Prospectively |
Last Modified On: |
06/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Comparing two different nerve Blocks for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block. |
Scientific Title of Study
|
Comparison of Ultrasound Guided Pericapsular Nerve Group Block with Suprainguinal Fascia Iliaca Block for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block. |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prachi Ranjan |
Designation |
Post Graduate Resident |
Affiliation |
Vardhman Mahavir College And Safdarjung Hospital |
Address |
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi
South DELHI 110029 India |
Phone |
7908277893 |
Fax |
|
Email |
prachifcb3@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nidhi Agrawal |
Designation |
Professor & Consultant |
Affiliation |
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi
South DELHI 110029 India |
Phone |
9811030408 |
Fax |
|
Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Nidhi Agrawal |
Designation |
Professor & Consultant |
Affiliation |
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi
South DELHI 110029 India |
Phone |
9811030408 |
Fax |
|
Email |
nidhi.agrawal1970@gmail.com |
|
Source of Monetary or Material Support
|
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi |
|
Primary Sponsor
|
Name |
Prachi Ranjan |
Address |
Department of Anaesthesia Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi- 110029 |
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 |
Prachi Ranjan |
Vardhman Mahavir College And Safdarjung Hospital |
Department Of Anaesthesia, Ground floor, Main OT Building. South DELHI |
7908277893
prachifcb3@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, Vardhaman Mahavir College and Safdargunj Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M20-M25||Other joint disorders, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
ULTRASOUND GUIDED PERICAPSULAR NERVE GROUP BLOCK |
: For ultrasound guided pericapsular nerve group block
The regional block will be performed with the patient in the supine position. Using strict aseptic precautions a curvilinear low-frequency ultrasound probe (2-5 MHz, M Turbo, SonoSite Inc., USA) 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 skin wheal of local anaesthetic will be made 1 cm away from the lateral edge of the ultrasound probe. A 22-gauge, 100-mm long echogenic 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. Following negative aspiration, the local anaesthetic solution (20 ml of 0.25% bupivcaine) will be injected in 5-mL increments while observing for adequate fluid spread in this plane. Duration of procedure is 20-30 minutes.
|
Comparator Agent |
ULTRASOUND GUUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK |
Ultrasound guided suprainguinal fascia iliaca block
The suprainguinal approach to the FICB has also been described using a more proximal needle insertion point.With the patient supine, a linear high frequency probe (6-14 MHz)is placed in the sagittal plane to obtain an image of the ASIS.The probe is moved medially and the fascia iliaca and sartorius, iliopsoas, and internal oblique muscles are identified. After identifying the ‘bowtie sign’ formed by the muscle fasciae, a 100 mm needle is introduced from caudal to cephalad using an in plane approach. The needle tip is positioned beneath the fascia iliaca,cephalad to inguinal ligament and hydro-dissection isused to separate the fascia iliaca from the iliacus muscle. The needle is further advanced in this space in a cranial and slightly dorsal direction. The deep circumflex artery lies superficial to the fascia iliaca and upward movement of this artery upon injection can be used as a marker of fascia iliaca penetration. Following negative aspiration, the local anesthetic solution (30 ml of 0.25% bupivacaine) will be injected in 5 ml increments while observing for adequate fluid spread in this plane. An injection is considered successful if spread of local anaesthetic is observed cranial to the point where the iliac muscle passes under the abdominal muscles. Duration of procedure is 20-30 minutes.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Study will be conducted in patients in age group of 18 to 80 years belonging to American society of Anaesthesiologist (ASA) physical status I and II scheduled for Hip fracture surgery under Subarachnoid block |
|
ExclusionCriteria |
Details |
Patients who can sit comfortably without requirement of analgesia
Patients having contraindication for Subarachnoid block
Patients with known allergy to local anesthetic drugs
Patients with Pre-existing peripheral nerve neuropathies and having fractures in multiple bones
Patients receiving chronic analgesic Therapy
Patients with infection over injection site
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
Compare Analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia Iliaca block measured by numerical rating scale score on passive limb elevation of 15 degrees at 30 minutes post block in patients with hip fracture before positioning for subarachnoid block. |
Before the block & at 30 minutes after the block |
|
Secondary Outcome
|
Outcome |
TimePoints |
Total amount of supplemental fentanyl if required to reduce pain on 15 degrees limb elevation at 30 minutes after administration of block.
NRS score on positioning patient for subarachnoid block
Ease of positioning score
Quality of patient’s position for subarachnoid block
Patient’s satisfaction with the nerve block
|
30 minutes after the block |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
20/07/2023 |
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
|
N/A |
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 Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prachifcb3@gmail.com].
- For how long will this data be available start date provided 01-07-2023 and end date provided 08-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
This study is a Prospective randomized interventional comparative study with an aim to to compare analgesia
provided by ultrasound guided pericapsular nerve group block with that of suprainguinal
fascia iliaca block in patients with
hip fracture before positioning for subarachnoid block.This study will be done in single centre in india. In this study- 1.Pre Procedural pain will be
assessed during rest as well as movement of 15° passive elevation of affected
limb and recorded on numeric pain rating scale (NRS) 0=no pain,10=worst
imaginable pain.
2. At 30mins after administering
the block, pain will be measured by NRS at rest and on passive limb elevation of
15°. (Primary objective)
If the patient reports a NRS
score ≥4 during 15° passive elevation of affected limb, intravenous
fentanyl 0.5 μg/kg body weight will be given and 15° passive elevation of
affected limb will be re-attempted after 5 minutes. If still NRS score is ≥4
then Inj. fentanyl 0.5 μg/kg body weight will be repeated every 5 minutes up to
maximum of 3 doses.
3. Patient will be made to
sit up for positioning for subarachnoid block after NRS score on 15 degree
passive limb elevation is < 4 or after 3 doses of fentanyl have been given
and NRS pain score will be noted on
sitting up the patient for positioning for subarachnoid block.
4. Total amount of supplemental
fentanyl if required for decreasing NRS pain score on 15° passive elevation of affected
limb at 30 minutes after administration of block will be noted.
5. The ease of spinal positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 =
patient had abnormal posturing due to pain and required support for positioning,
2 = mild discomfort but does not require support for positioning, 3 = optimal
condition where the patient was able to position himself without pain).
6. Quality of patient
position for subarachnoid block as assessed by anaesthesiologist performing
subarachnoid block will be evaluated as
0=Unsatisfactory,
1=Satisfactory, 2=Good or 3=Optimal.
Subarachnoid block will be performed using a median or
paramedian approach at the L3-L4 or L4-L5 interspace using spinal needle using
3 ml of 0.5% bupivacaine + fentanyl 10 µg.
7. Heart rate, non invasive
blood pressure (systolic ,diastolic, Mean), respiratory rate and SpO2
will be recorded ; a) at rest at 5, 10 ,20, 30 minutes after performing the
block procedure, b) on 15 degree passive
limb elevation at 30 minutes after performing the block and c) on positioning patient
( in sitting up position ) for subarachnoid block.
Intraoperative monitoring of heart rate,
noninvasive blood pressure (systolic, diastolic and mean) and SpO2 will be
done.
8. Complications such as
hypotension (a decrease of mean blood pressure >20% from preanaesthetic
baseline values), bradycardia (HR <40 beats/min), hypoventilation (breathing
rate <8 breaths/min), nausea and vomiting and signs of LA toxicity will be
noted and treated. After surgery, all patients will be transferred to post
anesthesia care unit, and hemodynamic parameters will be monitored. All
patients will receive paracetamol 1gm intraveously 8 hourly.
9.Patient satisfaction score
will be noted after positioning patient in sitting up position for subarachnoid
block:
Score 1- Good (Will
definitely accept the block again in future if required).
Score 2- Poor (will never
accept the block again in future if required).
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