| CTRI Number |
CTRI/2025/12/098689 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the duration of analgesia in PENG block and FIC block for hip surgeries using MgSO4 with Bupivacine as adjuvant |
|
Scientific Title of Study
|
Comparison of Post Operative Analgesia In Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block with Bupivacaine 0.25 percent with Magnesium Sulphate 750mg In Patients Undergoing Hip 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 |
HITHESH B R |
| Designation |
Post graduate resident |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Room 1 ,department of Anaesthesia , MIMS Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9035270450 |
| Fax |
|
| Email |
hitheshraju97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHIVAKUMAR G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesia
3RD CROSS, Guthal Rd, MARUTHI NAGAR, Mandya, Karnataka 571403
Mandya
KARNATAKA
571403
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muralidhara KS |
| Designation |
Assistant professor |
| Affiliation |
Mandya institute of Medical Science |
| Address |
Room 1 ,department of Anaesthesia , MIMS Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9980797972 |
| Fax |
|
| Email |
Muralidhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical science |
|
|
Primary Sponsor
|
| Name |
Mandya institute of medical science |
| Address |
Department of Anaesthesia
3RD CROSS, Guthal Rd, MARUTHI NAGAR, Mandya, Karnataka 571403 |
| 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 |
| Hithesh |
Mandya institute of medical sciences |
3RD CROSS, Guthal Rd, MARUTHI NAGAR, Mandya, Karnataka 571403
Mandya
KARNATAKA |
9035270459
hitheshraju97@gmail.con |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-MIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Usg guided PENG block vs fascia illaca compartment block |
30 ml of drug is used to deposit with usg guidence at peng block and sifi block over 15 mins |
| Comparator Agent |
Usg guided PENG blockvs fascia illacac compartment block |
Comparison of Post Operative Analgesia In Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block with Bupivacine 0.25% with Magnesium Sulphate 750 mg In Patients Undergoing Hip Surgeries “ |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing elective hip surgery at mandya institute of medical sciences
2)Patients of both sexs aged between 18 to 60 years .Patients belonging to ASA grade 1 and 2
3) Patients willing to give informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Patient with cardo vascular or cerbro vascular or peripheral vascular disease
2) Patients with uncontrolled diabetes mellitus or bleeding disorder
ASA 3 and ASA 4
Patient allergic to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of of post operative Analgesia of PENG block versus FICB block using MgSo4 as adjuvant for patient undergoing hip surgeries |
Post operative 2hr,4 hr ,8hr,12 hr,18hr,24 hr,30hr,36hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare early mobilisation post operative period in PENG & FICB block group & use of MgSo4 |
Post operative 2hr,4 hr ,8hr,12 hr,18hr,24 hr,30hr,36hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/12/2025 |
| 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="0"
Days="0" |
|
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
|
Study is useful for hip surgeries to relieve pain pre operative and post operative duration of analgesia using Bupivacine 0.25% with MgSo4 750mg has adjuvant in PENG block and Sifi block |