| CTRI Number |
CTRI/2025/10/095811 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effect of Pericapsular Nerve Group (PENG) Block with Radiocontrast in Patients Undergoing Hip Surgery” |
|
Scientific Title of Study
|
Assessing the Spread of Local Anaesthetic Injection Bupivacaine 0.25 percent(30ml) Using Radiocontrast Dye in Pericapsular Nerve Group (PENG) Block for Hip Surgeries – A Case Series |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahish Bhat K |
| Designation |
Postgraduate Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,DM-MCH hostel, Room number 606,15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560090
India |
| Phone |
9481123633 |
| Fax |
|
| Email |
ahishkbhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashidhar |
| Designation |
Assistant Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,DM-MCH hostel, Room number 606,15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560090
India |
| Phone |
9481123633 |
| Fax |
|
| Email |
ahishkbhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ahish Bhat K |
| Designation |
Postgraduate Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,DM-MCH hostel, Room number 606,15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560090
India |
| Phone |
9481123633 |
| Fax |
|
| Email |
ahishkbhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, sapthagiri institute of medical science and research centre, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri institute of medical science and research centre |
| Address |
DM MCH HOSTEL ROOM NO.606 15 Hesarghatta Rd Navy Layout AGB layout Chikkabanavara Bengaluru Karnataka 560090 |
| Type of Sponsor |
Private 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 |
| Ahish Bhat K |
Sapthagiri institute of medical science and research centre |
DM MCH HOSTEL ROOM NO.606 15 Hesarghatta Rd Navy Layout AGB layout Chikkabanavara
Bangalore
KARNATAKA |
9481123633
ahishkbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical science and research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W011||Fall on same level from slipping,tripping and stumbling with subsequent striking against object, (2) ICD-10 Condition: V281||Motorcycle passenger injured in noncollision transport accident in nontraffic accident, (3) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ultrasound-guided PENG block |
Ultrasound-guided PENG block with 30 ml of 0.25% Bupivacaine mixed with iohexol radiocontrast dye (OMNIPAQUE), spread of anaesthetic will be assessed at 0, 5, 10, 15, 20 min, with grading for ease of positioning and VAS score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Elective hip surgery under spinal anaesthesia.
2)ASA Physical Status I and II
3)Written informed consent provided. |
|
| ExclusionCriteria |
| Details |
1)Allergy to local anaesthetics or radiocontrast agents.
2)Coagulopathy or ongoing anticoagulant therapy.
3)Local infection at injection site.
4)Pregnant or lactating women.
5)Acute and chronic kidney disease patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the spread of injection Bupivacaine 0.25%, 30ml in myofascial plane in ultrasound guided PENG block in elective hip surgeries in tertiary hospital for post op analgesia in terms of VAS score and ease of positioning for spinal anaesthesia |
Spread is assessed at 0min, 5min, 10 min, 15 min and 20min along with ease of positioning and VAS score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
20/10/2025 |
| 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="0"
Months="0"
Days="5" |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- 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
Response - None of the above
- 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 (Others) - Upon reasonable request after publication
- For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective observational case series designed to evaluate the anatomical spread and clinical efficacy of the Pericapsular Nerve Group (PENG) block in patients undergoing elective hip surgeries. Severe pain in hip fracture patients often makes positioning for subarachnoid block (SAB) difficult. The PENG block is a novel ultrasound-guided regional anaesthesia technique targeting the articular branches of the femoral, obturator, and accessory obturator nerves, potentially providing superior analgesia. In this study, 10 adult patients, above 18 years, scheduled for hip surgeries under spinal anaesthesia will receive an ultrasound-guided PENG block with 30 ml of 0.25 bupivacaine mixed with iohexol radiocontrast dye (OMNIPAQUE). The injectate spread will be visualised using C-ARM imaging at 5, 10, and 20 minutes after injection. Primary outcome: Anatomical spread pattern of the injectate as seen on C-ARM imaging and Reduction in pain intensity measured by Visual Analogue Scale (VAS) at baseline, immediately post-block, and at 10, 15, and 20 minutes and Ease of positioning for SAB graded on a 0–3 scale. The findings will help understand the spread characteristics of the PENG block, optimise block techniques, and provide baseline data for future larger controlled trials.
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