| CTRI Number |
CTRI/2023/10/058472 [Registered on: 10/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dexmedetomidine and Dexamethasone, Which is a better adjuvant with Ropivacaine in Adductor canal block? |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Dexamethasone as adjuvant to Ropivacaine in Ultrasound guided Adductor canal block , for postoperative analgesia in knee Arthroscopic surgeries. A Randomised double blind study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muhsina K |
| Designation |
DNB Resident |
| Affiliation |
BLK Super Speciality Hospital |
| Address |
Department of Aneasthesiology
BLK Super Speciality Hospital
Pusa Road, New Delhi, 110005
New Delhi
DELHI
110005
India |
| Phone |
9539888198 |
| Fax |
|
| Email |
muhsinaasees@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Saraya |
| Designation |
senior consultant |
| Affiliation |
BLK Super Speciality Hospital |
| Address |
Department of Anaesthesiology,
BLK Super Speciality Hospital,
Pusa Road, New Delhi. 110005
Department of Anaesthesiology,
BLK Super Speciality Hospital,
Pusa Road, New Delhi. 110005
New Delhi
DELHI
110005
India |
| Phone |
9539888198 |
| Fax |
|
| Email |
chetansaraya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muhsina K |
| Designation |
DNB Resident |
| Affiliation |
BLK Super Speciality Hospital |
| Address |
Department of Anaesthesiology,
BLK Super Speciality Hospital,
Pusa Road, New Delhi, 110005
New Delhi
DELHI
110005
India |
| Phone |
9539888198 |
| Fax |
|
| Email |
muhsinaasees@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLK Super Speciality Hospital, Pusa Road, New Delhi, 110005 |
|
|
Primary Sponsor
|
| Name |
BLK Super Speciality Hospital |
| Address |
BLK Super Speciality Hospital,
Pusa Road, New Delhi,
110005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Muhsina K |
BLK Super Speciality Hospital |
Department of Anaesthesiology,
Pusa Road, New Delhi, 110005
New Delhi
DELHI |
9539888198
muhsinaasees@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLK SUPER SPECIALITY HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M239||Unspecified internal derangement of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adductor canal block |
Ultrasound guided single shot adductor canal block with 20 ml of 0.375% Ropivacaine and adjuvants |
| Comparator Agent |
Dexmedetomidine and Dexamethasone. |
Dexmedetomidine (1 microgram/kilogram body weight) singleshot injection in adductor canal as adjuvant to 20 ml Ropivacaine(0.375%) and
Dexamethasone (0.1 milligram/ kilogram body weight) single shot injection in adductor canal as adjuvant to 20 ml Ropivacaine(0.375%) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Elective knee arthroscopic surgeries under sub arachinoid block, giving consent to postoperative adductor canal block.
Age within 18 to 65, belonging to either gender.
American society of anaesthesiologists grade I and II
|
|
| ExclusionCriteria |
| Details |
Allergy to any of the drugs used.
Any contraindication to adductor canal block and Sub Arachinoid Block, like local infection.
History of diseases like diabetic neuropathy or any other neuropathy.
Any liver dysfunction or renal dysfunction.
Body mass index more than 35.
Patients who are on any anticoagulants or sedatives or having any deranged coagulation profile.
Pregnant females.
Patients with partial Sub Arachinoid Block, in need of additional analgesia during surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of total analgesia duration. |
Total requirement of rescue analgesia over a period of 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PATIENT SATISFACTION SCORE
EARLY TOE MOBILITY
HEMODYNAMIC STABILITY
SIDE EFFECTS, IF ANY |
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/10/2023 |
| Date of Study Completion (India) |
30/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is being conducted as part of Post Graduation Curriculum, Our aim is to compare Dexmedetomidine and Dexamethasone as adjuvant to Ropivacaine in Ultrasounded guided Adductor canal block for knee Arthroscopic surgeries. We are planning to include patients undergoing elective knee Arthroscopic surgeries under Sub Arachinoid block, who are American Society of Anaesthesiologists grade I and II. We are intenting to finish the study in 18 months. |