| CTRI Number |
CTRI/2025/08/093105 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the post operative pain reduction between two interventional nerve block techniques in the participants involving the patients undergoing hip surgeries and analyzing their outcomes |
|
Scientific Title of Study
|
Comparing the postoperative analgesic effect between the ultrasound guided Pericapsular Nerve Group PENG block and Fascia Iliaca Compartment Block FICB in intertrochanteric hip fracture surgeries
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palani Sukumar |
| Designation |
Junior Resident |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu
Chennai TAMIL NADU 600078 India |
| Phone |
9361349906 |
| Fax |
|
| Email |
sukuvinoth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aswini L |
| Designation |
Associate Professor |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu
Chennai TAMIL NADU 600078 India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswini.mbbs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aswini L |
| Designation |
Associate Professor |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu
Chennai TAMIL NADU 600078 India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswini.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND HOSPITAL,ASHOK PILLAR MAIN ROAD,KK NAGAR,CHENNAI |
|
|
Primary Sponsor
|
| Name |
Esic Medical College and Hospital |
| Address |
B block, 1st floor, Department of Anaesthesiology,Ashok Pillar Main Road, KK Nagar,Chennai 600078 |
| 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 |
| SUKUMAR |
ESIC MEDICAL COLLEGE AND HOSPITAL |
B block , 1st floor, Department of Anaesthesiology, Operating Room no 3,4 . Chennai TAMIL NADU |
9361349906
sukuvinoth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Esic medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascia Iliaca Compartment Block under Ultrasound guidance |
30 ml local anesthetic injected with 0.25 percent bupivacaine (28 ml) and 8 mg of
Dexamethasone (2 ml) |
| Intervention |
Pericapsular Nerve Group Block under Ultraound guidance |
30 ml of local anesthetic 0.25percent bupivacaine (28 ml) and 8 mg of dexamethasone (2 ml) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 40 to 70 years old who underwent isolated intertrochanteric fracture surgeries provided written consent
Both sex
Belonging to
ASA 1 ASA 2 and 3 physical status |
|
| ExclusionCriteria |
| Details |
Patient refusal for PENG or FICB
Patients who are not cooperative
Revision surgeries
Known allergies to local anaesthetics
Infection at the site of injection
ASA physical status of 4 and above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare postoperative analgesic effect between PENG (pericapsular nerve
group block) and FICB (fascia iliaca compartment block) in intertrochanteric hip
fracture surgeries via the visual analog scale (VAS) |
30 minutes to 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time of first request of rescue analgesia between pericapsular nerve group block
and fascia iliac compartment block. |
0 minutes to 24 hours |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="11" 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
|
|
Brief Summary
|
This randomized double blinded clinical trial will be conducted at ESIC Medical College and Hospital Chennai, after approval from the institutional ethics committee. Informed written consent will be obtained from all the participants of the study. All the patients scheduled for elective intertrochanteric hip fracture surgeries between the age group 40 to 70 years of either sex belonging to ASA 1,2 and 3 will be included in the study. On the day of surgery, spinal anaesthesia will be given for the surgery as per standard institutional protocol. Randomization will be done by a computer-generated table of random numbers. The allocation list will be generated and concealed in sealed envelopes. One envelope will be opened for each eligible candidate and the patient will be allocated to one of the two groups. The patient and the principal investigator will be blinded to this study. An Anaesthesiologist trained in these blocks will be performing the procedure. After surgery, under sterile aseptic precautions, patients in the Group A will receive an ultrasound guided pericapsular nerve group block using 0.25 percentage bupivacaine 28 ml and 8 mg of dexamethasone 2 ml. Patients in the Group B will receive an ultrasound guided Fascia Iliac compartment block using 0.25 percentage bupivacaine 28 ml, and 8 mg of dexamethasone 2 ml. Once the regional block is complete the patient will be shifted to the PACU post anaesthesia care unit for further observation. The study will start from the time the patient is shifted to PACU. The postoperative analgesia effect and other parameters such as heart rate, blood pressure, oxygen saturation spo2, first time of rescue analgesia, total opioid consumption, adverse effects, degree of range of motion by HARRIS HIP SCORE at 0min, 15 min,30min,1 hour,2 hrs, 4hrs,8hrs,12 hrs and 24hrs after blockade. The injection of tramadol 1mg per kg mg intravenous sos will be considered as rescue analgesia if Visual Analogue Scale more than 4. Nausea, which is one of the most common side effects of tramadol, will be treated with injection Ondansetron 0.1 mg per kg intravenous. |