CTRI Number |
CTRI/2022/07/043834 [Registered on: 07/07/2022] Trial Registered Prospectively |
Last Modified On: |
06/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Two different block for pain relief after hip surgeries |
Scientific Title of Study
|
To evaluate the effect of ultrasound guided Fascia iliaca compartment block (FIC) and Pericapsular Nerve Group (PENG) block on the postoperative analgesia in patients undergoing 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 Geeta Singariya |
Designation |
Senior Professor |
Affiliation |
Dr S N Medical Collage Jodhpur |
Address |
Dr S N medical collage Jodhpur 123 Vaishali Avenue Jhawar road JODHPUR Jodhpur RAJASTHAN 342001 India |
Phone |
09414803554 |
Fax |
|
Email |
geetamanojkamal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manish Garg |
Designation |
Junior Resident |
Affiliation |
Dr S N medical Collage Jodhpur |
Address |
Dr S N Medical Collage Jodhpur Main OT Complex, First floor, M D M Hospital, Shastri Nagar, Jodhpur (Rajasthan) Jodhpur RAJASTHAN 342001 India |
Phone |
8930877119 |
Fax |
|
Email |
mkgarg93@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Geeta Singariya |
Designation |
Senior Professor |
Affiliation |
Dr .S N Medical collage Jodhpur |
Address |
Dr S N medical Collage Jodhpur Main OT Complex, First floor, M D M Hospital, Shastri Nagar, Jodhpur (Rajasthan) Jodhpur RAJASTHAN 342001 India |
Phone |
09414803554 |
Fax |
|
Email |
geetamanojkamal@gmail.com |
|
Source of Monetary or Material Support
|
Dr S N Medical College Jodhpur |
|
Primary Sponsor
|
Name |
Dr S N Medical Collage and attached hospital Jodhpur |
Address |
Shastri Nagar Jodhpur Rajasthan |
Type of Sponsor |
Government medical college |
|
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 Geeta Singariya |
MDM hospital, Dr S N Medical Collage, Jodhpur |
Main OT Complex, first floor, Department of Anaesthesia, MDM hospital, Dr. S.N. medical collage, Jodhpur Jodhpur RAJASTHAN |
9414803554
geetamanojkamal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr S N Medical College Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint, (2) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group FIC |
Participants will receive fascia iliaca compartment block after spinal anesthesia, patients will receive 30 ml of 0.5% levobupivacaine |
Comparator Agent |
Group PENG |
Participants will receive pericapsular nerve group block after spinal anesthesia, patients will receive 30 ml of 0.5% levobupivacaine |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA physical status I and II undergoing hip surgeries (duration about 2.5 hours) |
|
ExclusionCriteria |
Details |
Patient refusal
Uncooperative patient
Hypersensitivity to local amide anaesthetics Infection at the injection site
Pregnant woman
Obesity
Uncooperative patients
Prior surgery at the corresponding area
Bleeding disorders
Peripheral neuropathy or neurological deficit Known hepatic or renal insufficiency
Patient on concurrent chronic opioid or any other analgesic therapy, |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Duration of analgesia after ultrasound-guided Fascia iliaca compartment (FIC) block and Pericapsular Nerve Group (PENG) block on the postoperative analgesia in patients undergoing hip surgeries |
24 HOURS |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Analgesic consumption in post operative 24 hours
2. To assess quality of analgesia by using NRS score
3. Assessment of motor block during post operative 24 hours
4. Haemodynamic parameters
5. Complications
6. Patient satisfaction
|
24 HOURS |
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
11/07/2022 |
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="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetamanojkamal@gmail.com].
- For how long will this data be available start date provided 24-09-2022 and end date provided 24-09-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
The study will be conducted in Mahatama Gandhi hospital and Mathura Das Mathur Hospital of Dr S. N. Medical College and associated group of hospitals, Jodhpur after seeking clearance from the institutional ethical committee and obtaining written, informed consent from the patients. All patients will be examined during the preoperative visits, prior to surgery by an attending anesthesiologist. During the preoperative visit patient’s detailed history, general physical examination and systemic examination will be carried out. Basic demographic data like name, age, sex, height, and weight will be recorded. A detailed assessment of the airway will be performed to rule out any airway difficulty. Routine investigations will be carried out. Patients will be explained in detail about the procedure, drugs and the Numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain). The standard instruction of fasting will be given to all patients. After the arrival of the patient in the operation theatre, saturation monitors like continuous electrocardiogram (ECG), non-invasive blood pressure (NIBP) and peripheral oximetry will be applied on arrival to the operation theatre and baseline vitals will be recorded. A peripheral intravenous (IV) line will be secured with an 18 G cannula on the forearm and a 0.5ml/kg/hr crystalloid solution will be started. All the patients will receive spinal anaesthesia with 0.5% bupivacaine 15 mg (3 ml) heavy under all aseptic precautions. The block will be performed as per randomization, once the spinal anaesthesia effect is confirmed. The block will be performed with an ultrasound machine. With the participants in a supine position, in group FIC block, the probe will place in a horizontal direction over the anterior part of the thigh just below the inguinal ligament. The ultrasound setting uses to visualise at a frequency of 10 MHz and a depth of 3-4 cm. The femoral artery will identify first. Group FIC, the iliacus muscle, covered by fascia iliaca will be identified lateral to the artery. A 20 G needle was then inserted in-plane into the ultrasound beam. The needle advance until the tip of the needle will place beneath the fascia iliaca and after negative aspiration, the local anaesthetic of 30 ml of 0.5% levobupivacaine will be injected and its spread visualized on the ultrasound screen. Group PENG block, the anterior inferior iliac spine, the femoral artery (FA), the pectineus muscle, the iliopubic eminence, the iliopsoas muscle and tendon could be observed using a curvilinear low-frequency ultrasound probe. The puncture site will be set 0.5-1.0 cm away from the lateral of the ultrasound probe. A 22-gauge, 80-mm needle will be inserted carefully in an in-plane approach from lateral to inner. Following the tip of the needle reaches the musculofascial between the tendon of the psoas muscle anteriorly and the pubic ramus posteriorly, which is between the iliopubic eminence and anterior inferior iliac spine, 1 mL of 0.9% saline solution will be injected to ensure that the solution will be spread in the plane beneath the iliopsoas muscle. After negative aspiration, a total volume of 30mL of 0.5% levobupivacaine will be slowly injected after negative aspiration every 5 mL. The ultrasound view of the fluid spread in the plane will be observed to ensure that the LA is injected right into the targeted location. |