| CTRI Number |
CTRI/2025/07/091356 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound guided 4 in 1 block technique for knee and below knee surgeries for post operative pain control. |
|
Scientific Title of Study
|
Ultrasound guided four in one Block technique on post operative analgesia in patients posted for KNEE AND BELOW KNEE surgeries under spinal anaesthesia A SINGLE ARM CLINICAL TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinivas Bandanavar |
| Designation |
Post graduate in department of anaesthesia |
| Affiliation |
Vijaynagar institue of medical SCIENCES ballari |
| Address |
Department of anaesthesia major ot complex ballari medical college and research Centre Vijaya Nagar cantonment Ballari
Door no 12 ward no 17 miller pet near water tank ballari 583103
Bellary
KARNATAKA
583104
India |
| Phone |
9945202286 |
| Fax |
|
| Email |
srinivasbandanavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr parimala |
| Designation |
Professor |
| Affiliation |
Vijaynagar institue of medical SCIENCES ballari |
| Address |
Department of anaesthesiology major ot complex Ballari medical college and research Centre Vijaya Nagar cantonment Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9742530338 |
| Fax |
|
| Email |
dr.parimaladu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr parimala |
| Designation |
Professor |
| Affiliation |
Vijaynagar institue of medical SCIENCES ballari |
| Address |
Department of Anaesthesiology major ot complex Ballari medical college and research Centre Vijaya Nagar cantonment Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9742530338 |
| Fax |
|
| Email |
dr.parimaladu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology Ballari medical college and research Centre Ballari 583104 |
|
|
Primary Sponsor
|
| Name |
Dr Srinivas Bandanavar |
| Address |
Department of anaesthesiology major ot complex Ballari medical college and research Centre |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Srinivas Bandanavar |
Ballari medical college and research Centre ballari |
Ot room no 1 2 and 6 department of anaesthesiology PMSSY Superspeciality hospital and Trauma Care Centre BMCRC Ballari
Bellary
KARNATAKA |
9945202286
srinivasbandanavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ballari medical college and research Centre ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Postoperative analgesia of 4 in 1 nerve block |
For 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for unilateral total knee replacement surgery knee and below knee surgery Age 20 to 70 years
Males and females
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
patient refusal to 4 in 1 nerve block and spinal anaesthesia
Patient with neurological and psychiatric disorder severe cardiovascular respiratory hepatic and renal diseas
Allergy to study drugs
Patients with coagulopathies and other contraindications to regional anaesthesia. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia |
Duration of a post operative analgesia extends from the time of regional block till NRS score more than 4 and nrs score assessed at 30 mins 1hr 2hr 4hr 8hr 12hr 16hr 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score by nrs |
30 mins 1 hr 2 hr 4 hr 8hr 12 hr 24 hr |
| Straight leg Raising Test |
12 hr and 24 hr |
| Cumulative dose of rescue analgesia |
24 hrs |
| Patient satisfaction by likert scale |
12 hr and 24 hr |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="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
|
|