| CTRI Number |
CTRI/2024/07/071711 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two spinal anaesthesia drugs given in spinal anaesthesia for bone fracture surgery. |
|
Scientific Title of Study
|
A Comparative study of Intrathecal hyperbaric levobupivacaine 5 mg versus hyperbaric bupivacaine 5 mg in spinal anaesthesia for orthopaedic surgery. |
| 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 Ushma H Thakar |
| Designation |
Second Year Resident |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Anesthesiology Department
Smt SCL General Hospital Saraspur Cross Road Saraspur Ahmedabad
Ahmadabad
GUJARAT
380018
India |
| Phone |
9909245913 |
| Fax |
|
| Email |
thakarushma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri M Panjabi |
| Designation |
Associate Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Room no 216,
Anesthesiology Department
Smt SCL General hospital, Saraspur Cross Road, Saraspur, Ahmedabad
Ahmadabad
GUJARAT
380005
India |
| Phone |
9377244003 |
| Fax |
|
| Email |
gauripanjabi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri M Panjabi |
| Designation |
Associate Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Room no 216,
Anesthesiology Department
Smt SCL General hospital, Saraspur Cross Road, Saraspur, Ahmedabad
Ahmadabad
GUJARAT
380005
India |
| Phone |
9377244003 |
| Fax |
|
| Email |
gauripanjabi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| The drug will be indented from our hospital, Smt SCL General hospital, Saraspur Cross Road, Saraspur, Ahmedabad, Gujarat, India. 380018 |
|
|
Primary Sponsor
|
| Name |
Smt SCL General Hospital |
| Address |
Saraspur cross road, saraspur, ahmedabad. 380018 |
| Type of Sponsor |
Other [corporation hospital] |
|
|
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 Ushma H Thakar |
Smt SCL General Hospital |
2nd floor old building, Ortho-platic Operation Theatre, Orthopaedic Ward
Ahmadabad
GUJARAT |
9909245193
thakarushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHL Institutional Review Board(NHLIRB) |
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 |
Intrathecal Hyperbaric bupivacaine |
It has been widely used as an intrathecal anesthetic agent of choice for regional anesthesia.120-180 minutes |
| Comparator Agent |
Intrathecal hyperbaric levobupivacaine |
It is a pure s (-) enantiomer of bupivacaine, a safe alternative for regional anesthesia.120-180 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Elective lower limb orthopaedic surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusing to give consent
Known hypersensitivity to study drugs
Respiratory, Cardiovascular, Renal or Hepatic disease(ASA Grade 3 and 4)
Blood Coagulopathies
Patient with peripheral neuropathy
Patient with local sepsis or spinal deformity |
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MOTOR AND SENSORY BLOCK CHARACTERISTICS |
1 Time required to achieve sensory block up to T10 level.
2 Time required to achieve maximum level of sensory block.
3 Time required to achieve modified bromage scale.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEMODYNAMIC STABILITY DURING INTRAOPERATIVE PERIOD (PULSE RATE, BLOOD PRESSURE & SPO2 MONITORING) |
Baseline,
At 1 minute after Spinal anaesthesia,
At 3 minutes after spinal anaesthesia,
At 5 minutes after spinal anaesthesia,
At 10 minutes after spinal anaesthesia,
At 15 minutes after spinal anaesthesia,
At 20 minutes after spinal anaesthesia,
At 30 minutes after spinal anaesthesia,
At 40 minutes after spinal anaesthesia,
At 50 minutes after spinal anaesthesia,
At 60 minutes after spinal anaesthesia.
|
| QUALITY OF ANAESTHESIA |
Excellent
Good
Fair
Poor |
| COMPLICATIONS |
Hypotension
Bradycardia
Nausea & vomiting
Shivering |
| DURATION OF BLOCK |
Complete recovery of sensory block
Complete recovery of motor block |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
10/10/2024 |
| Date of First Enrollment (Global) |
15/08/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 STUDY WILL ONLY START AFTER I GET THE CTRI APPROVAL FOR THE STUDY. I WANT TO DO THIS RESEARCH TO GET TO KNOW THE BETTER DRUG FOR SPINAL ANAESTHESIA. |