| CTRI Number |
CTRI/2025/03/082427 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of efficacy of suprainguinal block versus local infilteration for post operative pain in hip surgeries |
|
Scientific Title of Study
|
comparison of suprainguinal fascia iliaca block with local infilteration after hip surgeries for post operative analgesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sethupathy |
| Designation |
junior resident |
| Affiliation |
Dr.D.Y. Patil Medical college,Hospital and Research Centre |
| Address |
Department of anaesthesia, 5th floor,HI-Tech building,Dr.D.Y.PATIL Medical college,hospital and research centre,Sant Tukaram nagar, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9698817815 |
| Fax |
|
| Email |
dr.sethu23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor |
| Affiliation |
Dr.D.Y. Patil Medical college,Hospital and Research Centre |
| Address |
Department of anaesthesia, 5th floor,HI-Tech building,Dr.D.Y.PATIL Medical college,hospital and research centre,Sant Tukaram nagar, Pimpri,
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor |
| Affiliation |
Dr.D.Y. Patil Medical college,Hospital and Research Centre |
| Address |
Department of anaesthesia, 5th floor,HI-Tech building,Dr.D.Y.PATIL Medical college,hospital and research centre,Sant Tukaram nagar, Pimpri,
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, HI-TECH building,Dr D Y PATIL Medical college hospital and research centre Sant Tukaram nagar Pimpri
Pune Maharashtra Pincode-411018 |
|
|
Primary Sponsor
|
| Name |
Sethupathy P |
| Address |
Department of anaesthesia 5th floor HI-Tech building
Dr D Y PATIL Medical college hospital and research centre Sant Tukaram nagar Pimpri
Pune |
| 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 |
| Dr Aparna Bagle |
Dr D Y Patil hospital and Research Centre |
Department of Anaesthesia 5th Floor Hi-tech building Dr D Y Patil Medical college Hospitaland Research Centre Sant Tukaram Nagar Pimpri
Pune
MAHARASHTRA |
9834430811
draparnabagle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local infiltrations |
At the end of Hip surgery, patient will be given local infiltration of anaesthesia with 0.25 % Bupivacaine Hydrochloride at the incision site |
| Intervention |
Suprainguinal fascia iliaca block versus local infiltration |
at the end of Hip surgery, patient will be given suprainguinal fascia iliaca block with 30ml 0.25% Bupivacaine hydrochloride under USG guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Patients undergoing hip surgeries
Patients who is willing to participate in this study |
|
| ExclusionCriteria |
| Details |
ASA III or more
Patient denied to participate in study
Patient with contraindication for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare efficacy of suprainguinal fascia iliaca block versus local infilteration |
1 Post operative VAS score
2 Time to first rescue analgesic
3 Total analgesic consumption in first 24 hours
4 Postoperative hemodynamic parameter
5 Time required to mobilize the patient
6 To observe any side effects
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any side effects and hemodynamic changes |
postoperative |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="6"
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
|
ASA 1 and 2 patients who is eliglable to participate in this study will be enrolled after getting CTRI registration. Efficacy of suprainguinal fascia iliaca block versus local infiltration will be measured by recording VAS postoperatively at 2,4,6,8,12,16,24 and 48 hrs. Total analegic requirement in first 24hrs will be noted. |