Comparision of two nerve group blocks to study better pain relief during positioning of patients.

Not yet recruiting

Conditions: Unspecified fracture of femur,

Registration Number: CTRI/2025/05/086515

Lead Sponsor: Mahatma Gandhi Memorial Medical college and MYHospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

ASA Physical status score of I,II,III, Hip fracture patients taken for elective surgery.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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
1.Visual Analogue scale score	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
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh
🇮🇳
Indore, MADHYA PRADESH, India
Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh
🇮🇳Indore, MADHYA PRADESH, India
DR ARAVINDHAN V
Principal investigator
9524154441
aravindvelzgt@gmail.com