| CTRI Number |
CTRI/2020/02/023197 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy of Buprenorphine and Clonidine when combined with Ropivacaine in spinal anesthesia of leg surgeries. |
|
Scientific Title of Study
|
Comparision between plain Ropivacaine, Ropivacaine with Buprenorphine and Ropivacaine with Clonidine for intrathecal use in lower limb orthopaedic surgeries - A prospective randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasanth D |
| Designation |
Post Graduate |
| Affiliation |
Shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia
Shri sathya medical college and research Institute
Guduvanchery Thiruporur main road
Ammapettai
Nellikuppam
Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8220320737 |
| Fax |
|
| Email |
vasanth_1686@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri sathya sai medical college and research Institute |
| Address |
Department of anaesthesia
Shri sathya medical college and research Institute
Guduvanchery Thiruporur main road
Ammapettai
Nellikuppam
Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasanth D |
| Designation |
Post Graduate |
| Affiliation |
Shri sathya sai medical college and research institute |
| Address |
Department of anaesthesia
Shri sathya medical college and research Institute
Guduvanchery Thiruporur main road
Ammapettai
Nellikuppam
Chengalpattu taluk
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8220320737 |
| Fax |
|
| Email |
vasanth_1686@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
Vasanth D |
| Address |
Sri lakshmi illam
M2 136
R M Colony
Dindigul 624001
Tamilnadu |
| 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 |
| Vasanth D |
Shri sathya sai medical college and research institute |
Department of Anaesthesiology
ORTHO OT
OT number 3
Second
Floor OT Complex
Thiruporur
Guduvanchery Main
Road Ammapettai
Nellikuppam
Kancheepuram 603108
Tamil Nadu India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8220320737
vasanth_1686@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M80-M85||Disorders of bone density and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine |
Before the beginning of surgery, 0.75% Ropivacaine 3ml (22.75 mg ) given intrathecally.Using this drug spinal anaesthesia given single shot. |
| Comparator Agent |
Buprenorphine |
Before the beginning of surgery,Buprenorphine 0.2ml ( 60mcg ) added with 0.75% Ropivacaine 3ml ( 22.75% ) given intrathecally.Using this drug spinal anaesthesia one time. |
| Comparator Agent |
Clonidine |
Before the beginning of surgery, clonidine 0.2ml ( 30mcg ) added with 0.75% Ropivacaine 3ml ( 22.75% ) given intrathecally.Using this drug spinal anaesthesia given one time. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective upper limb surgeries
American Society of Anaesthesiologist I or II |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Allergic to opioids/ local anaesthetics.
Height < 140 cm , BMI > 30
Patient with recent history of CVA.
Coagulation disorder.
Severe CVS abnormalities.
Poorly controlled hypertension.
Poorly controlled Diabetes mellitus.
Emergency orthopaedic surgery.
|
|
|
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 duration of analgesia of Ropivacaine, Buprenorphine with ropivacaine, Clonidine with ropivacaine given intrathecally in terms of first
rescue analgesia requirement |
Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for onset of sensory and motor blockade.
Intra operative haemodynamic changes.
To determine the quality of analgesia and post operative analgesic first required |
Intra operative period and post operative periods |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
30/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/10/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomised controlled trial to compare the plain ropivacaine, Buprenorphine with ropivacaine and Clonidine with ropivacaine given intrathecally for patient undergoing lower limb orthopaedic surgeries,among 75 patients are divided in 3 groups over a period of 18 months.The primary objective is to compare the duration of analgesia between 3 groups.The secondary objectives are onset of sensory blockade, haemodynamic changes during intra operative period and quality of analgesia post operatively. |