| CTRI Number |
CTRI/2023/08/056421 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Effect of Drug(Fentanyl and Bupivacaine) Given in spinal cord during lower limb surgeries and to assess its efficacy for patient well being |
|
Scientific Title of Study
|
Efficacy of intrathecal 0.5% Bupivacaine with fentanyl & 0.5% Bupivacaine with Butorphanol in lower limb surgeries |
| 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.R Ramachandran |
| Designation |
Doctor(Post Graduate) |
| Affiliation |
Sri Manakula vinayagar Medical College and Hospitals |
| Address |
Sri Manakula vinayagar Medical college and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Department of Anaesthesia,
Room No 108,Speciality OT,
Sri Manakula vinayagar Mediacal College and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9444905606 |
| Fax |
|
| Email |
ram1507@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.Dinesh Babu |
| Designation |
Doctor(Professor) |
| Affiliation |
Sri Manakula vinayagar Medical College and Hospitals |
| Address |
Sri Manakula vinayagar Medical college and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Department of Anaesthesia,
Room No 108,Speciality OT,
Sri Manakula vinayagar Medical college and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894109684 |
| Fax |
|
| Email |
babud569@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.R Ramachandran |
| Designation |
Doctor(Post Graduate) |
| Affiliation |
Sri Manakula vinayagar Medical College and Hospitals |
| Address |
Sri Manakula vinayagar Medical college and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Department Of Anaesthesia,
Room no 108,Speciality OT,
Sri Manakula vinayagar Medical college and hospital,
Kalitheerthalkuppam,Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9444905606 |
| Fax |
|
| Email |
ram1507@icloud.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical college and Hospital,Kalitheerthalkuppam,
Madagadipet,Puducherry |
|
|
Primary Sponsor
|
| Name |
DR Ramachandran R |
| Address |
Sri Manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,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 Ramachandran R |
Sri Manakula vinayagar medical college and hospital |
Department of Anaesthesiology,
kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY |
9444905606
ram1507@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayagar Medical College and Hospital,Pondicherry,605107 |
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 |
| Comparator Agent |
Fentanyl and Butorphanol |
Efficacy of intrathecal Bupivacaine with Fentanyl and Bupivacaine with Butorphanol |
| Intervention |
Treatment for Post-op analgesia with Fentanyl and Butorphanol |
Intervention to treat Post-op analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient Posted for lower limb surgical and orthopaedic procedures
Patient who are accepted under ASA PS1 and ASA PS2 |
|
| ExclusionCriteria |
| Details |
Patient who refused to give consent for study
Patient who are haemodynamically unstable |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of motor & sensory blockade between 0.5% bupivacaine with Fentanyl
and 0.5% Bupivacaine with butorphanol |
Motor & sensory blockade checked every 15 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
haemodynamic parameters between two drugs
|
compare the post operative analgesia between two drugs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/08/2023 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The main aim of the study is to compare the efficacy of intrathecal 0.5% Bupivacaine with Fentanyl and Burophanol using spinal anaesthesia. |