| CTRI Number |
CTRI/2024/07/070598 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy of 2 different drugs used in Adductor canal block in knee surgeries |
|
Scientific Title of Study
|
A Comparitive study between 0.25% Ropivacaine with dexmedetomidine and dexamethasone as adjuvants in adductor canal block for post operative analgesia in knee 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 |
Niyati Singh |
| Designation |
PG 3rd year Anaesthesia Resident |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesia
Sardar Patel Medical College Bikaner Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
8527036545 |
| Fax |
|
| Email |
dr.niyatisingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner Rajasthan-334001
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner Rajasthan-334001
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College Bikaner-334001 Rajasthan India
|
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesia
Sardar Patel Medical College Bikaner
Rajasthan-334001 |
| 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 |
| Dr Sonali Dhawan |
Sardar Patel medical college |
Department of anaesthesia, sardar patel medical college, Bikaner, Rajasthan
Bikaner
RAJASTHAN |
9414137866
sonaligsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board,SPMC,Bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S832||Tear of meniscus, current injury, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided adductor canal block using Ropivacaine with dexamethasone and dexmedetomidine as adjuvants for knee surgeries |
Under all aseptic precautions, painting and draping will be done. A high-frequency linear array ultrasound transducer will be used to identify the adductor canal. The transducer will be placed at the mid-thigh, half the distance between the inguinal crease and the patella. Next, the superficial femoral artery will be identified dorsal/lateral to the sartorius muscle in short-axis. At this level, the hyperechoic structure located lateral/anterior to the artery will be identified as the target site at the adductor canal.For subjects in the adductor canal group, a 21G 100mm Echoplex+ needle is placed lateral to the superficial femoral artery and within the adductor canal, using an in-plane ultrasound technique.A 21G 100mm Echoplex+ needle will be advanced 1 to 2 cm into the adductor canal and the drug will be injected.Ropivacaine 0.25% with dexmedetomidine(50mcg)in one case and dexamethasone(4mg) in other case total volume 20 ml is injected. |
| Intervention |
USG guided adductor canal block using Ropivacaine with dexamethasone and dexmedetomidine as adjuvants for knee surgeries |
Under all aseptic precautions, painting and draping will be done. A high-frequency linear array ultrasound transducer will be used to identify the adductor canal. The transducer will be placed at the mid-thigh, half the distance between the inguinal crease and the patella. Next, the superficial femoral artery will be identified dorsal/lateral to the sartorius muscle in short-axis. At this level, the hyperechoic structure located lateral/anterior to the artery will be identified as the target site at the adductor canal.For subjects in the adductor canal group, a 21G 100mm Echoplex+ needle is placed lateral to the superficial femoral artery and within the adductor canal, using an in-plane ultrasound technique.A 21G 100mm Echoplex+ needle will be advanced 1 to 2 cm into the adductor canal and the drug will be injected.Ropivacaine 0.25% with dexmedetomidine(50mcg)in one case and dexamethasone(4mg) in other case total volume 20 ml is injected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status 1,2,3
Patients undergoing elective knee surgery
18-75 years |
|
| ExclusionCriteria |
| Details |
ASA Physical Status 4 and above
patient refusal
known allergy to drug used in the study
pregnant female
history of bleeding diathesis
patient on anticoagulation
infection at the site of block placement
history of any active liver and renal disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Efficacy of 0.25% Ropivacaine with Dexmedetomidine (Group A) and 0.25% Ropivacaine with Dexamethasone (Group B) in Adductor Canal Block in terms of
1. Duration of post operative analgesia
2. Total analgesic consumption in 48 hours |
Evaluate on the basis of NRS Score at different interval of 20min,40min,1hour,6hour,12hour,18hour,24hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe any side effects and complications related to drugs and technique
2.To observe patient satisfaction |
1.Time taken to perform adductor canal block
2.Duration of effective analgesia
3.Time of first rescue analgesics given
4.Total Analgesic consumption in 24 hrs
5.Assessment scale for post-operative nausea and vomiting |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="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
|
Our Aim is to compare the efficacy of 0.25% Ropivacaine with dexmedetomidine (Group A) and dexamethasone (Group B) in adductor canal block in knee surgeries in terms of :
1. Duration of post-operative analgesia 2.Total Analgesic consumption in 24hrs
|