| CTRI Number |
CTRI/2021/03/032274 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
04/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effective post-operative onset of pain effect of two drug combinations Bupivacaine with Fentanyl and Bupivacaine with Dexmedetomidine in lower limb surgeries |
|
Scientific Title of Study
|
A Comparative study of Post-operative Analgesic Effect of Intrathecal Bupivacaine with Fentanyl versus Intrathecal Bupivacaine with Dexmedetomidine in lower limb surgeries-A Double Blind Randomized Controlled study |
| Trial Acronym |
CPOAEITBFVBDLLS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Arjun |
| Designation |
1st year, Post graduate trainee Anesthesiology |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
A block, first floor, department of Anesthesiology, Aarupadai Veedu Medical College & Hospital, Kirumampakkam, Pondicherry Cuddalore highway, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9849549505 |
| Fax |
|
| Email |
arjun.1115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Ezhilrajan |
| Designation |
H.O.D & Professor |
| Affiliation |
Aarupadai Veedu Medical college & Hospital,Pondicherry |
| Address |
A block, first floor, department of Anesthesiology, Aarupadai Veedu Medical College & Hospital, Kirumampakkam, Pondicherry Cuddalore highway, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Ezhilrajan |
| Designation |
H.O.D & Professor |
| Affiliation |
Aarupadai Veedu Medical college & Hospital,Pondicherry |
| Address |
A block, first floor, department of Anesthesiology, Aarupadai Veedu Medical College & Hospital, Kirumampakkam, Pondicherry Cuddalore highway, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical college & Hospital |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical college Hospital |
| Address |
Aarupadai Veedu Medical College & Hospital, Kirumampakkam, Pondicherry Cuddalore highway, Pondicherry. |
| 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 P Arjun |
Aarupadai Veedu Medical college & Hospital |
A block, first floor, department of Anesthesiology, Aarupadai Veedu Medical College & Hospital, Kirumampakkam, Pondicherry Cuddalore highway, Pondicherry.
Pondicherry
PONDICHERRY |
9849549505
arjun.1115@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN 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: M858||Other specified disorders of bonedensity and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl and Dexmedetomidine |
Fentanyl 0.5ml(50micrograms)
Dexmedetomidine 0.5 ml(25 micrograms) |
| Intervention |
Spinal Anesthesia with Bupivacaine |
Spinal Anesthesia is the choice of regional Anesthesia for lower limb Orthopedic and General Surgery procedures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-65yrs of either sex
Orthopedic and General Surgeries lasting for 1-2 hrs
Patients of ASA-I & II
Patients weighing 50-80kgs. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to any of the drugs
Uncontrolled Diabetes Mellitus and Hypertension
Renal and Liver failures
Cardiac dysrhythmias
Coagulopathies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Post-operative Pain Analgesia of Intrathecal Bupivacaine with Fentanyl versus Intrathecal Bupivacaine with Dexmedetomidine |
12 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory blockade
Motor blockade
|
Sensory-8hrs
Motor-8hrs
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/03/2021 |
| 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="8"
Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Summary of this study is to compare the Post-operative onset of pain between the two Intrathecal drug combinations i.e. Bupivacaine with Fentanyl versus Bupivacaine with Dexmedetomidine. |