| CTRI Number |
CTRI/2024/03/064724 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical study by scanning for administering anaesthesia for below knee surgeries. |
|
Scientific Title of Study
|
A Randomized Double Blind Comparative Study Of Ultrasound Guided Adductor Canal And Popliteal Block For Providing Anaesthesia To Below Knee Surgeries Using 0.5% Bupivacaine With Dexamethasone Versus 0.5% Bupivacaine With Dexmedetomidine. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya Hirguppe Somashekhar |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Room No. 01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8277152369 |
| Fax |
|
| Email |
aditya.hs2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kumar P B |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Room No. 01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9448279414 |
| Fax |
|
| Email |
drrameshkumarpb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kumar P B |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Room No. 01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
KARNATAKA
560060
India |
| Phone |
9448279414 |
| Fax |
|
| Email |
drrameshkumarpb@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Aditya Hirguppe Somashekhar |
| Address |
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India |
| 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 Aditya Hirguppe Somashekhar |
BGS Global Institute of Medical Sciences |
Department of Anaesthesiology, 3rd Floor, No. 67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8277152369
aditya.hs2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
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 |
| Comparator Agent |
Bupivacaine and Dexamethasone |
Single dose injection of 30ml of 0.5% Bupivacaine with 8 milligrams of Dexamethasone for popliteal and adductor canal block. |
| Intervention |
Bupivacaine and Dexmedetomidine |
Single dose injection of 30ml of 0.5% Bupivacaine with 0.5 microgram/kg Dexmedetomidine for popliteal and adductor canal block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to ASA physical status I and II.
2. Patients posted from orthopedics and general surgery specialties for elective below knee surgeries.
3. Patients willing to give informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of anaphylaxis to local anaesthetics and/or opioids and the study drugs to be used.
2. Patients with a history of drug abuse and psychiatric disease.
3. Morbidly obese patients of BMI greater than 35 kg per meter square.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess, compare and evaluate the onset and duration of sensory and motor blockade, and duration of postoperative analgesia with hemodynamic parameters.
|
5 minutes,10 minutes,15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, and 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the procedure & intervetnion |
15 minutes, 30 minutes, 1 hour, 2 hours ,4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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
|
Peripheral nerve block provides anaesthesia,
analgesia, early ambulation, and a shorter hospital stay. Through various
adjuvants like opioids, steroids, magnesium,alpha 2 agonists , etc.have been used in peripheral nerve blocks for
many years, the quest for a newer adjuvant for nerve blocks continues. With
good knowledge of dermatomes, myotomes and osteotomes of lower limb and the use
of ultrasound for precise perineural deposition of local anaesthetics, there is
an increase in the success rate with prolonged duration and decrease in the
incidence of complications associated with peripheral nerve blocks. The
effectiveness of two additives used in the popliteal nerve block for below knee
surgery to prolong the duration and effectiveness of anaesthesia has been
examined individually by multiple studies and have suggested that additives may
have a positive effect on peripheral nerve blocks. |