| CTRI Number |
CTRI/2024/06/069383 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| 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
|
To compare the anaesthetic and analgesic efficacy of plain ropivacaine with ropivacaine and dexmedetomidine in patients of manipur undergoing lower limb surgeries using ultrasound guided combined femoral and sciatic nerve block as a randomised clinical trial |
|
Scientific Title of Study
|
Comparative evaluation of half percent Ropivacaine with ropivacaine half percent and Dexmedetomidine in Ultrasound guided combined Femoral and Sciatic nerve block for lower limb surgeries. A Randomized clinical 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 |
Vigneshwaravibhava K |
| Designation |
Postgraduate trainee |
| Affiliation |
Regional Institute Of Medical Sciences, Manipur University |
| Address |
Department of Anaesthesiology, Regional Institute Of Medical Sciences, Imphal.
Imphal West
MANIPUR
795004
India |
| Phone |
8072260511 |
| Fax |
|
| Email |
vkvibhava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Longjam Eshori |
| Designation |
Associate Professor |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
| Address |
Department of Anaesthesiology, RIMS, Imphal.
Imphal West
MANIPUR
795004
India |
| Phone |
9436036407 |
| Fax |
|
| Email |
drlongjam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Longjam Eshori |
| Designation |
Associate Professor |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL |
| Address |
Department of Anaesthesiology, Regional institute of medical sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9436036407 |
| Fax |
|
| Email |
drlongjam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional institute of medical sciences, Imphal, Manipur, India 795004 |
|
|
Primary Sponsor
|
| Name |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, Regional institute of medical sciences, Imphal, Manipur, India 795004 |
| 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 Vigneshwaravibhava K |
Regional institute of medical sciences |
Department of Anaesthesiology, Regional institute of medical sciences, Imphal, Manipur, India 795004
Imphal West
MANIPUR |
8072260511
vkvibhava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
| Intervention |
Inj. Ropivacaine 0.5% and Inj. Dexmedetomidine 25 mcg. |
Study participants will be randomized into two groups. Group B patients will receive 40 ml of drug solution containing Ropivacaine 0.5% and Dexmedetomidine 25mcg in ultrasound guided combined femoral and sciatic nerve block usig locoplex syringe. |
| Comparator Agent |
Inj.Ropivacaine 0.5% |
Study participants will be randomized into two groups A and B. Group A patients will receive 40 ml of drug solution containing 0.5% Ropivacaine in Ultrasound guided combined femoral and sciatic nerve block using locoplex syringe. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sex: Either sex
Age: 18 to 65 years
ASA Grade I or II patients scheduled for elective lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative patients / unwilling patients
2.Hypersensitivity to amide group of Local anaesthetic agents and dexmedetomidine
3.Patients having hypertension / diabetes mellitus / neuropathy / peripheral nerve injury
4.Pregnancy and lactation
5.Patient on anticoagulants or bleeding disorder
6.Local site infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Anaesthetic and analgesic efficacy of the two drug combinations used in the study. |
Outcome will be assessed during the intraoperative and postoperative period from the time of onset of sensory and motor blockade till the time of first rescue analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="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
|
This
study will be a randomized double blinded, prospective, comparative study, to
be carried out in 60 patients, of ASA I and II undergoing lower limb surgery
with combined femoral and sciatic nerve block.
The
patients will be randomly divided into two groups of 30 each. Group A (n=30)
will receive inj. 0.5% Ropivacaine (40ml) with 25 micrograms dexmedetomidine.
Group B (n=30) will receive inj. 0.5% plain Ropivacaine (40ml).
The
onset and duration of sensory block, motor block, post- operative analgesia, time
to first rescue analgesic and side effects will be assessed and recorded.
All the
findings and observations made during the entire study will be tabulated,
graphically depicted whenever possible, statistically analysed and inference
drawn to evaluate and compare the two groups on sensory and motor block onset,
duration and side effects. |