CTRI Number |
CTRI/2025/05/086515 [Registered on: 07/05/2025] Trial Registered Prospectively |
Last Modified On: |
06/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Comparision of two nerve group blocks to study better pain relief during positioning of patients. |
Scientific Title of Study
|
Analgesic Efficacy of Ultrasound guided pericapsular nerve group block versus fascia iliaca compartment block for positioning pain during spinal anaesthesia in hip fractures - A Randomised comparitive study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Aravindhan V |
Designation |
Junior Resident |
Affiliation |
Mahatma Gandhi Memorial Medical College |
Address |
Department of Anaesthesiology ,M.Y Hospital and Mahatma Gandhi Memorial Medical College,Indore,Madhya Pradesh
Indore MADHYA PRADESH 452001 India |
Phone |
9524154441 |
Fax |
|
Email |
aravindvelzgt@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR Deepali Valecha |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Memorial Medical College |
Address |
Mahatma Gandhi Memorial Medical College and M.Y hospital, Indore, Madhya Pradesh pin code 452001
Indore MADHYA PRADESH 452001 India |
Phone |
9424405404 |
Fax |
|
Email |
deepalisidhwani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR Deepali Valecha |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Memorial Medical College |
Address |
Department of Anaesthesiology ,Mahatma Gandhi Memorial Medical college and M.Y Hospital Indore Madhya Pradesh pin code 452001
Indore MADHYA PRADESH 452001 India |
Phone |
9424405404 |
Fax |
|
Email |
deepalisidhwani@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology ,M.Y Hospital and Mahatma Gandhi Memorial Medical College ,Indore ,Madhya Pradesh , India pin code 452001. |
|
Primary Sponsor
|
Name |
Mahatma Gandhi Memorial Medical college and MYHospital |
Address |
Department of Anaesthesiology ,Mahatma Gandhi Memorial Medical College and M.Y Hospital Indore Madhya Pradesh India pin code 452001. |
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 ARAVINDHAN V |
Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh |
Ground Floor , Operation theatre complex ,Department of Anaesthesiology office, MY Hospital ,Indore, Madhya Pradesh, India pincode 452001. Indore MADHYA PRADESH |
9524154441
aravindvelzgt@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS AND SCIENTIFIC REVIEW COMMITTEE, M.G.M MEDICAL COLLEGE, M.Y HOSPITAL ,INDORE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Fascia iliaca nerve group block |
patients of one group will receive fascia iliaca compartment block ultrasound guided with 20ml of 0.25% bupivacaine and will be monitored for 15 minutes after giving block. |
Intervention |
Pericapsular nerve group block |
patients of one group will receive pericapsular nerve group block ultrasound guided with 20ml of 0.25% Bupivacaine and will be monitored for 15 minutes after giving block. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA Physical status score of I,II,III, Hip fracture patients taken for elective surgery |
|
ExclusionCriteria |
Details |
Patient refusal for consent, patients with bleeding diathesis, skin pathology at injection site, patients with known allergy to study drugs, patients with neurological and psychiatric illness |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To compare the analgesic efficacy of the ultrasound guided pericapsular nerve group block with fascia iliaca compartment block for positioning pain during spinal anaesthesia in hip fracture patients in terms of
1.Visual Analogue scale score
2.Ease of spinal positioning using ease of positioning scale |
A 10 point Visual Analogue Score (VAS) will be recorded before and immediately after the intervention at 0mins immediately after block followed by 2minutes ,5 minutes ,10 minutes and 15 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
To observe hemodynamic changes in the period from time of nerve block to positioning for spinal anaesthesia |
Hemodynamic parameters such as heart rate, Mean arterial pressure, oxygen saturation will be recorded at baseline 0 minutes after intervention also at 2 minutes, 5 minutes, 10 minutes, 15 minutes. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
17/05/2025 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
- Who will be able to view these files?
Response - Anyone
- 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 (Others) -
- For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
INTRODUCTION Hip fractures are associated with severe morbidity and mortality. These fractures require early surgical fixation and subarachnoid block is preferred as mode of anaesthesia. But, severe pain during positioning may complicate the procedure of subarachnoid block. Nerve blocks such as femoral nerve block, peri capsular nerve group block, fascia iliaca compartment block can help us in reducing positional pain. Ultrasound guidance has shown to increase the precision and effectiveness of these blocks. Therefore this study aims to compare the efficacy between usg guided pericapsular nerve group block and fascia iliaca compartment block for positioning of patients of hip fractures for subarachnoid block. METHODOLOGY After receiving approval from the Institutional Ethical Committee of M.G.M Medical College, 100 ASA grade 1,2 and 3 patients posted for elective surgery will be included in the study. Patients will be explained about the procedure and due risks involved in their own language and informed consent will be taken. On the day of surgery, patients will be allocated either of the two groups group PENG and FICB. As soon as patient enter the operation theatre, intravenous access will be obtained and preloading with Ringer lactate at the rate of10ml/kg will be started. Baseline Vital parameters will be noted. Group PENG Ultrasound guided pericapsular nerve group block will be given by using 20 ml of 0.25% bupivacaine. Group FICB Ultrasound guided fascia iliaca compartment block will be given by using 20 mL of 0.25% bupivacaine. A 10 point Visual Analogue Score VAS will be recorded before and immediately after the intervention at 0,2, 5, 10 and 15 minutes. Patients with VAS score 3 or less than 3 after 15 minutes will be positioned sitting position for subarachnoid block and Ease of spinal positioning will be assessed according to the scale. Ease of positioning scale EOP scale 0– Unable to position 1- Patient with abnormal position due to pain or required support for position 2- Mild discomfort but does not require support for position 3- Optimal position. Patient with EOSP more or equal to 2 will be considered as acceptable position. Patients with VAS score more than 3 even after 15 minutes will be provided additional analgesia i.e injection paracetamol 15 mg/kg to alleviate Pain and will be excluded from the study. Hemodynamic parameters such as Heart rate, Mean arterial pressure, oxygen saturation will be recorded at baseline, after intervention at 2min, 5 min, 10 min, 15 min. Adverse effects like nausea, vomiting,bradycardia, hypotension, abscess formation, hematoma allergic reactions, local Anaesthetic systemic toxicity or any other if present will be noted and managed by standard medical protocol. REFERENCES: 1. Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. PMID: 32231802; PMCID: PMC7091518. 2. Dr. Amarnath Naik Korra, Dr. Rajendra Kiran Brahmaroutu, Dr. AS Kameswara Rao. Comparative evaluation between fascia iliaca compartment block and intravenous fentanyl administration for painless positioning during spinal Anaesthesia in fracture femur surgeries: A randomized controlled study. Int J Med Anesthesiology 2020;3(1):306-310. DOI: 10.33545/26643766.2020.v3.i1e.106 3. Kaur G, Saikia P, Dey S, Kashyap N. Pericapsular nerve group (PENG) block—a scoping review. Ain-Shams J Anesthesiol. 2022;14(1):29. doi: 10.1186/s42077-022-00227-0. Epub 2022 Mar 14. PMCID: PMC8919174. 4. Kalashetty MB, Channappa Gowda R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9. PMID: 36620112; PMCID: PMC9813981. 5. Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, et al. Management of proximal femoral fractures 2011. Anaesthesia . 2012 Jan;67(1):85–98. Available from: http://doi.wiley.com/10.1111/j.1365- 2044.2011.06957.x 6. Van Waesberghe J, Stevanovic A, Rossaint R, et al. General vs. neuraxial anaesthesia in hip fracture patients: a systematic review and meta-analysis. BMC Anesthesiol. 2017;17. DOI:10.1186/s12871-017-0380-9. 7. Madabushi,Rajappa,ThammannaPP,etal.Fascia iliaca block vs intravenous fentanyl as an analgesic technique before positioning for spinal anesthesia in patients undergoing surgery for femur fractures—a randomized trial. J Clin Anesth. 2016;35:398–403. 8. Girón-Arango L, Peng PWH, Chin KJ, et al. Pericapsular nerve group (PENG) block for hip fracture. Reg Anesth Pain Med. 2018;43:1. 9. Kumar A, Sinha C, Kumar A, et al. Positioning of fracture femur patients for spinal anaesthesia: femoral nerve block or intravenous fentanyl? Bali J Anesthesiol. 2018;2:61. 10. Sia S, Pelusio F, Barbagli R, et al. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg. 2004;99:1221–1224. |