| CTRI Number |
CTRI/2022/04/041726 [Registered on: 07/04/2022] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for anaesthesia in spinal block for lower limb surgery |
|
Scientific Title of Study
|
“Comparison of intrathecal hyperbaric Ropivacaine 0.75% and hyperbaric Bupivacaine 0.5% in lower limb orthopaedic surgery-A prospective randomised double blind comparative study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Sharma |
| Designation |
Associate professor |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology, RNT Medical college
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929929987 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Sharma |
| Designation |
Associate professor |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology, RNT Medical college
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929929987 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
santosh choudhary |
| Designation |
Assistant Professor |
| Affiliation |
RNT Medical college |
| Address |
Department of Anaesthesiology, RNT Medical college
Udaipur
RAJASTHAN
313001
India |
| Phone |
09462102856 |
| Fax |
|
| Email |
DRSANCHOUDHARY@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, MB Government Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
RNT Medical College Udaipur |
| 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 |
| Santosh Choudhary |
MB Govt Hospital |
Trauma building, Second Floor, Orthopedics Operation Theater
Udaipur
RAJASTHAN |
09462102856
DRSANCHOUDHARY@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE&CONTROLLER & ATTACHED HOSPITAL, UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: S822||Fracture of shaft of tibia, (3) ICD-10 Condition: S821||Fracture of upper end of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine Heavy 0.5% |
3 ml (15mg) 0.5% hyperbaric bupivacaine in Spinal Block |
| Comparator Agent |
Ropivacaine Heavy (0.75%) |
with 3 ml (22.5mg) 0.75% hyperbaric Ropivacaine in Spinal block. |
| Intervention |
Spinal Ropivacaine and Bupivacaine |
• Group B (Bupivacaine group)- Patients will receive subarachnoid block with 3 ml (15mg) 0.5% hyperbaric bupivacaine.
• Group R (Ropivacaine group) - Patients will receive subarachnoid block with 3 ml (22.5mg) 0.75% hyperbaric Ropivacaine.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status Grade I and II of either sex.
Patients in the age group of 18-60 years.
Posted for lower limb orthopedic surgeries under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients posted for emergency surgeries.
Pregnant patients.
Patients having coagulation abnormalities, platelet count <75,000, INR >1.5, or on anticoagulants.
Patients having systemic illness (severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic/ valvular/ congenital heart diseases, psychiatric, hematological disorder).
Patients having any absolute contraindications for spinal anesthesia.
Patient refusal to participate in study.
Any allergy to study drugs or local anaesthetic drugs.
Short stature (height <150cms), with spinal deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
4 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory block, onset and duration of motor block and hemodynamic parameters. |
Intraoperative (3-4 hours) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2022 |
| Date of Study Completion (India) |
15/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our original study is comparison of intrathecal 0.5 % bupivacaine heavy and 0.75% ropivacaine heavy for lower limb surgeries in terms of duration of analgesia, block characterstics. kindly consider our study for ctri registration. |