| CTRI Number |
CTRI/2025/11/096783 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Two Types of Nerve Blocks (PENG and Supra-inguinal Fascia Iliaca) for Pain Relief and Muscle Strength After Hip Surgery |
|
Scientific Title of Study
|
Peng block vs. supra-inguinal fascia iliaca block: a comparative analysis of analgesia duration and motor blockade in hip surgery patients |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Sada Shiva Reddy |
| Designation |
Postgraduate Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
14/A, Old Golibar Maidan, Camp, Pune Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Pune MAHARASHTRA 411037 India |
| Phone |
9003126126 |
| Fax |
|
| Email |
sadashivreddy3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Aditya Sapra |
| Designation |
Head of Department |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Pune MAHARASHTRA 411040 India |
| Phone |
8197084270 |
| Fax |
|
| Email |
adityaspara@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
John M K |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Pune MAHARASHTRA 411040 India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra, 411040 |
|
|
Primary Sponsor
|
| Name |
G Sada Shiva Reddy |
| Address |
Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| John M K |
Armed Forces Medical College |
Department of Anaesthesiology, 1st floor, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra Pune MAHARASHTRA |
9765167438
majjohnmk9090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A will receive the Pericapsular Nerve Group (PENG) block |
Will be performed preoperatively under ultrasound guidance by trained anesthesiologists. For the PENG block, 25 ml of 0.25 ropivacaine will be administered targeting the pericapsular region between the psoas tendon and pubic ramus. For the SIFI block, 25 ml of 0.25 ropivacaine will be deposited in the supra-inguinal plane deep to the fascia iliaca, aiming for spread toward the femoral, lateral femoral cutaneous, and obturator nerves.
Postoperatively, patients will be assessed for pain using the Visual Analog Scale (VAS) at regular intervals (0, 4, 8, 12, and 24 hours). |
| Comparator Agent |
Group B will receive the Supra-inguinal Fascia Iliaca (SIFI) block |
Will be performed preoperatively under ultrasound guidance by trained anesthesiologists. For the PENG block, 25 ml of 0.25 ropivacaine will be administered targeting the pericapsular region between the psoas tendon and pubic ramus. For the SIFI block, 25 ml of 0.25 ropivacaine will be deposited in the supra-inguinal plane deep to the fascia iliaca, aiming for spread toward the femoral, lateral femoral cutaneous, and obturator nerves.
Postoperatively, patients will be assessed for pain using the Visual Analog Scale (VAS) at regular intervals (0, 4, 8, 12, and 24 hours). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 80 years.
ASA Physical Status I to III.
Scheduled for hip surgery (e.g., fracture fixation or arthroplasty).
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetics.
Coagulopathy or on anticoagulant therapy.
Infection at the block site.
Pre-existing motor/sensory deficit in lower limbs.
Cognitive impairment interfering with pain scoring.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of Analgesia (in hours)
Degree of Motor Blockade |
0, 2, 4, 8, 12, and 24 hours postoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain Scores at Defined Intervals
Time to First Rescue Analgesia
Total Rescue Analgesic Consumption
Patient Satisfaction Score
Time to First Ambulation
Incidence of Adverse Effects or Complications |
0, 2, 4, 8, 12, and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="1" |
|
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 - NO
|
|
Brief Summary
|
Hip fractures and surgeries in the elderly are associated with significant morbidity and mortality. Optimal pain control is crucial in perioperative management, facilitating early mobilization, reducing complications such as deep vein thrombosis and pulmonary embolism, and improving overall outcomes. Regional anesthesia techniques are frequently employed to provide effective analgesia while preserving motor function. The Pericapsular Nerve Group (PENG) block and Supra-inguinal Fascia Iliaca Block (SIFI) have gained attention for hip surgery analgesia. The PENG block, a newer technique, specifically targets articular branches of the femoral, obturator, and accessory obturator nerves innervating the anterior hip capsule. Performed under ultrasound guidance, it is designed to spare motor nerves, minimizing quadriceps weakness. This motor-sparing property is particularly advantageous in elderly patients, allowing early physiotherapy and ambulation. The SIFI block, a modification of the traditional fascia iliaca block, involves a higher injection site to facilitate spread toward the lumbar plexus. It provides broad coverage of the femoral, lateral femoral cutaneous, and obturator nerves. While offering robust analgesia, it has higher potential for motor blockade due to extensive nerve involvement, particularly affecting the quadriceps, which may delay postoperative mobilization. Despite growing utilization, there is lack of consensus regarding their comparative efficacy. Current literature presents conflicting results, with most studies limited by small sample sizes or heterogeneous methodologies. Our study aims to compare the PENG block versus SIFI block in hip surgery patients. Primary endpoints include analgesia duration, measured using standardized pain scores and time to first rescue analgesia, and degree of motor blockade assessed through objective motor function scales. Secondary outcomes include patient satisfaction, ease of administration, and incidence of complications. Understanding these techniques’ differential effects is crucial for guiding anesthesiologists toward the most appropriate block based on individual patient needs. In an aging population where functional preservation is as important as pain control, selecting a block providing effective analgesia without compromising mobility is essential |