| CTRI Number |
CTRI/2026/04/107544 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing ultrasound guided peripheral nerve group block and ultrasound guided femoral nerve block for the ease of positioning for central neuraxial blockade in patients of proximal segment femur fracture surgeries. |
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Scientific Title of Study
|
Peripheral Nerve Group Block Vs Femoral Nerve Block For Analgesia and Positioning in Proximal Femur Fractures: A Randomised Controlled Comparison |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rangoli Sao |
| Designation |
Junior Resident |
| Affiliation |
N K P Salve Institue of Medical Sciences and Research Centre. |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Digdoh Hills, Hingne Road.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9527241249 |
| Fax |
|
| Email |
rangolisao174@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Heena Pahuja |
| Designation |
Professor |
| Affiliation |
N K P Salve Institue of Medical Sciences and Research Centre. |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Digdoh Hills, Hingne Road.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9823188160 |
| Fax |
|
| Email |
heenapahuja15@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Heena Pahuja |
| Designation |
Professor |
| Affiliation |
N K P Salve Institue of Medical Sciences and Research Centre. |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Digdoh Hills, Hingne Road.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9823188160 |
| Fax |
|
| Email |
heenapahuja15@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rangoli Sao |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Digdoh Hills, Hingne Road, Nagpur, Maharastra 440019 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rangoli Sao |
NKP Salve Institute of Medical sciences and Research Centre and Lata Mangeshkar Hospital |
Department of anaesthesiology, orthopaedics Operation theartre ,NKP Salve Institute of Medical sciences and Research Centre and Lata Mangeshkar Hospital digdoh hills hingna road Nagpur Nagpur MAHARASHTRA |
9527241249
rangolisao174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee N K P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound Guided Femoral Block |
USG FNB will be given on the operating side (lower limb) with injection Ropivacaine 0.2 percent 15 cc. after that NRS score of the patient will be recorded and compared with the intervention group. |
| Intervention |
Ultrasound Guided Peripheral Nerve Group Block |
USG PENG block will be given on the operating side
(lower limb) with injection Ropivacaine 0.2percent 15 ml. after that NRS score will be recorded of the patient and compared with the comparison group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
posted for proximal segment femur fracture surgeries
patient oriented to time, place, person
ASA grade I, II, III |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is statistically significant difference between the decrease of NRS for ultrasound guided peripheral nerve block compared to ultrasound guided femoral nerve block in proximal segment femur fracture patients. Also there was significant difference in the patient satisfaction and anaesthesiologist satisfaction score at 30 mins of the block with better satisfaction in PENG block compared to FNB. |
There is statistically significant difference between the decrease of NRS for ultrasound guided peripheral nerve block compared to ultrasound guided femoral nerve block in proximal segment femur fracture patients at 0 mins, 10 mins, 20 mins, 30 mins. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative analgesia in first 24 hours after the block was better in PENG( intervention group) compared to FNB (comparison group). also haemodynamic stability was better at 0 min, 10 min, 20 min & 30 min in PENG group compared to FNB group. Quadricep muscles were spared in PENG block & the patient was able to lift the operating leg by 15 degrees after 30 mins of the block before central neuraxial blockade. |
haemodynamic stability was seen at 0mins, 10 mins, 20 mins, 30 mins. quadricep muscle power was seen at 30 mins of the block & post operative analgesia was seen for first 24 hours of the block. |
|
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Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
06/04/2026 |
| 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 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 - NO
|
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Brief Summary
|
Effective pain management is essential for ensuring optimal positioning during spinal anesthesia, especially in complex surgeries such as proximal femur fracture procedures. Proper positioning is critical for the accurate placement of the spinal needle and the overall effectiveness of the block. When patients are in discomfort, they may struggle to maintain the required posture—whether sitting or lying in a specific position—which can compromise the precision of needle placement. Effective pain control before positioning for CNB alleviates this discomfort, allowing patients to remain still and maintain the correct position, which is crucial for a successful CNB and minimizing complications like accidental dural puncture. Moreover, pain management directly impacts the efficacy of spinal anesthesia. By ensuring that patients are relaxed and comfortable, it enhances the ability to administer the anesthetic precisely where needed, improving the likelihood of achieving the desired level of anesthesia and analgesia. Pain control also helps streamline the procedure by reducing delays associated with repositioning or adjusting the patient due to discomfort. This contributes to a more efficient process and shorter overall procedure time. In addition to these technical benefits, effective pain management significantly improves the patient experience. Reducing pain and anxiety leads to a more positive experience, which can enhance patient cooperation and reduce overall stress during the procedure. Femoral nerve block is the most widely used standard peripheral block for ease of positioning in proximal femur fracture patients. However , recent advancements in multimodal pain management strategies, incorporating nerve blocks like ultrasound guided pericapsular nerve group block have demonstrated notable improvements in pain scores for ease of positioning in the femur fracture patients. Studies indicate that such strategies can reduce opioid consumption, improve pain scores, and decrease hospital stays. These advancements highlight the importance of preoperative pain management in optimizing recovery and enhancing surgical efficacy, ultimately underscoring its critical role in successful CNB and overall patient care. There are many studies showing the effects of these two individual blocks for ease of positioning for central neuraxial blockade, but very few showing the comparisons between these blocks to conclude which block gives better pain control for ease of positioning. For example, Kullenberg B.et al (2004),Francesca L.et al(2008),Purohit S. et al (2017),Acharya U.et al(2020), Morrison C. et al(2021) are some of the studies showing the effect of femoral nerve block and pericapsular nerve group block on pain control individually for ease of positioning in hip fractures. However, there are very less studies showing the comparison between these two blocks. The primary objective of this study was to compare the Ultrasound-guided PENG block and the Ultrasound-guided FNB for ease of positioning for CNB in patients undergoing surgery for proximal femur fractures in terms of pain score(NRS), anaesthesiologist satisfaction score and patient’s satisfaction score. To achieve these objectives, a randomized controlled trial (RCT) involving patients with proximal femur fractures is conducted from April 2025 to April 2026. Total of 52 Participants were randomly assigned to receive either the USG guided PENG block or USG guided FNB before positioning for CNB in groups of 26 each with injection Ropivacaine 0.2% 15 cc in each patient. Pain scores were assessed using Numerical rating score(NRS). Additionally, patient satisfaction and anaesthesiologist satisfaction were also assesed. The secondary objectives were to check for the total postoperative 24 hours analgesic requirement and quadriceps muscle power. |