| CTRI Number |
CTRI/2024/12/078422 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study between two doses of dexmedetomidine 0.5µg/KG and 1µG/kg as an adjuvant to 0.25% ropivacaine in adductor canal block for management of post operative pain in knee surgeries under spinal anaesthesia |
|
Scientific Title of Study
|
A comparative study of efficacy and safety of two different doses of dexmedetomidine – 0.5µg/Kg and 1µg/Kg as an adjuvant to 0.25% ropivacaine in ultrasound guided adductor canal block for postoperative analgesia in knee surgeries under spinal anaesthesia |
| 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. Ayushi Shastri |
| Designation |
Junior resident |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, AURANGABAD |
| Address |
Department of Anaesthesiology, MGM Medical college and hospital N6 CIDCO Aurangabad, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8120077366 |
| Fax |
|
| Email |
ayushishastri16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pramod Bhale |
| Designation |
Professor and Head of Department |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, AURANGABAD |
| Address |
Department of Anaesthesiology, MGM Medical college and hospital N6 CIDCO Aurangabad, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
pramod.bhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pramod Bhale |
| Designation |
Professor and Head of Department |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, AURANGABAD |
| Address |
Department of Anaesthesiology, MGM Medical college and hospital N6 CIDCO Aurangabad, Maharashtra, India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
pramod.bhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical college and hospital N6 CIDCO Aurangabad, Maharashtra, India. Pincode- 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Medical college and hospital |
| Address |
N6 CIDCO Aurangabad, Maharashtra, India
pincode- 431003 |
| Type of Sponsor |
Private 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 Ayushi Shastri |
MGM hospital |
OT no. 6, OT complex
Department of Anaesthesiology, MGM Medical college and hospital N6 CIDCO Aurangabad, Maharashtra, India. Pincode 431003
Aurangabad
MAHARASHTRA |
8120077366
ayushishastri16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics commitee for research on Human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group RD. Adductor canal block using 0.25% ropivacaine with 0.5µg/kg as an adjuvant. |
Patient in supine position with thigh abducted and externally rotated to allow access to medial thigh.
Transducer is placed anteromedially at the junction between middle and distal third of thigh.
Once femoral artery has been identified, The needle is inserted midplane lateral to medial orientation and advanced towards the femoral artery. When the needle tip is visualised anterior to the artery, once the nerve is visualised clearly, after negative aspiration of blood and spread confirmed, 20ml of 0.25% ropivacaine with 0.5µg/kg as an adjuvant will be given. |
| Comparator Agent |
Group RD1. Adductor canal block using 0.25% ropivacaine with 1µg/kg as an adjuvant. |
Patient in supine position with thigh abducted and externally rotated to allow access to medial thigh. Transducer is placed anteromedially at the junction between middle and distal third of thigh. Once femoral artery has been identified, The needle is inserted midplane lateral to medial orientation and advanced towards the femoral artery. When the needle tip is visualised anterior to the artery, once the nerve is visualised clearly, after negative aspiration of blood and spread confirmed, 20ml of 0.25% ropivacaine with 1µg/kg as an adjuvant will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
posted for elective knee surgeries under spinal anaesthesia
ASA grade II and II |
|
| ExclusionCriteria |
| Details |
Allergy to drugs used in study
Patients having contraindications to adductor canal blocks(local site infections, coagulopathies)
Known neurological deficits |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare postoperative analgesia using the numerical pain rating scale
2. To assess and compare number of rescue analgesics required within 24hrs |
0 MIN (MOMENT BLOCK IS GIVEN)
30 MIN
60 MIN
90 MIN
120 MIN
6 HOURS
12 HOURS
18 HOURS
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare motor blockade between two groups using modified bromage scale
2. To assess and compare haemodynamic parameters
3. To assess and compare sedation score between two groups
4. any adverse effects during first 24 hours post surgery |
0 MIN (MOMENT BLOCK IS GIVEN)
30 MIN
60 MIN
90 MIN
120 MIN
6 HOURS
12 HOURS
18 HOURS
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
Months="0"
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
|
Severe postoperative pain is a common complain post knee surgeries, affecting rehabilitation and early mobilization efforts. Regional anaesthesia forms an important part of the solution. regional anaesthesia specific to lower limb surgeries includes femoral nerve block, sciatic nerve block, obturator nerve block, lumbar plexus block and the adductor canal block. Adductor canal block is superior to femoral nerve block (considered the gold standard) in having an added advantage of motor sparing effect, which eliminates quadriceps weakness and thus helps in early mobilization post operatively.
In this study, we aim to primarily assess the efficacy of two different doses of dexmedetomidine 0.5mcg/kg and 1mcg/kg as an adjuvant to 0.25% ropivacaine in ultrasound guided adductor canal block in knee surgeries. And compare the number of rescue analgesics needed. Our secondary objective is to compare the motor blockade, sedation scores and hemodynamic stability between the two groups. |