CTRI Number |
CTRI/2022/12/048169 [Registered on: 15/12/2022] Trial Registered Prospectively |
Last Modified On: |
14/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARING THE EFFECTS OF TWO LOCAL ANAESTHESIA DRUGS FOR SPINAL ANESTHESIA |
Scientific Title of Study
|
COMPARING THE EFFECT OF INTRATHECAL DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC BUPIVACAINE AND HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
TEJA PAGADALA |
Designation |
JUNIOR RESIDENT |
Affiliation |
M S RAMAIAH MEDICAL COLLEGE |
Address |
DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE,
MSRIT POST, MSR NAGAR,
BANGALORE
Bangalore KARNATAKA 560054 India |
Phone |
8951858818 |
Fax |
|
Email |
teja.pagadala599@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
GEETHA C R |
Designation |
PROFESSOR AND HOD |
Affiliation |
M S RAMAIAH MEDICAL COLLEGE |
Address |
DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE,
MSRIT POST, MSR NAGAR,
BANGALORE
Bangalore KARNATAKA 560054 India |
Phone |
9900482828 |
Fax |
|
Email |
jageedha@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
GEETHA C R |
Designation |
PROFESSOR AND HOD |
Affiliation |
M S RAMAIAH MEDICAL COLLEGE |
Address |
DEPARTMENT OF ANESTHESIOLOGY, SECOND FLOOR, M S RAMAIAH MEDICAL COLLEGE,
MSRIT POST, MSR NAGAR,
BANGALORE
Bangalore KARNATAKA 560054 India |
Phone |
9900482828 |
Fax |
|
Email |
jageedha@yahoo.com |
|
Source of Monetary or Material Support
|
M S RAMAIAH MEDICAL COLLEGE,
MSRIT POST, MSR NAGAR,
BANGALORE |
|
Primary Sponsor
|
Name |
M S RAMAIAH MEDICAL COLLEGE |
Address |
MSRIT POST MSR NAGAR
BANGALORE 560054 |
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 Geetha C R |
M S RAMAIAH MEDICAL COLLEGE |
Department of Anesthesiology, Second floor, M S Ramaiah Medical College Hospital Bangalore KARNATAKA |
9900482828
jaheedha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS COMMITTEE M S RAMAIAH MEDICAL COLLEGE AND HOSPITALS |
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: S828||Other fractures of lower leg, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Sub-arachanoid block given with Hyperbaric Bupivacaine and Dexmedetomidine. |
2.8ml of 0.5% Hyperbaric Bupivacaine + 0.1ml of 50mcg/ml Dexmedetomidine administered and the study parameters noted till the effect of the drug is regressed. |
Intervention |
Sub-arachanoid block given with Hyperbaric Ropivacaine and Dexmedetomidine |
2.8ml of 0.75% Hyperbaric Ropivacaine + 0.1ml of 50mcg/ml Dexmedetomidine administered and the study parameters noted till the effect of the drug is regressed. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Elective lower limb Orthopedic surgeries.
American Society of Anesthesiologists Physical Status 1 and 2. |
|
ExclusionCriteria |
Details |
Patients refusal to participate in the study.
Contraindications to Spinal Anaesthesia.
Pregnant women and lactating mothers.
Patient allergic to Opiods and Local Anaesthetic drugs.
Patient height <150cms. |
|
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 |
To compare the effect on onset and duration of sensory block and onset and duration of motor block. |
The block will be assessed at 1 minute interval for the first 10 minutes, every 5 minutes in the first hour, every 10 minutes till the regression of block. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the effect on hemodynamic changes in both the groups like hypotension, bradycardia and side effects such as nausea, vomiting, pruritius and shivering. |
Hemodynamic parameters measured at every 2 minute intervals for the first 10
minutes followed by 5 minute intervals for the next 20 minutes and at 10 minute intervals till the end of the surgery. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
Date of First Enrollment (India)
|
20/12/2022 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [teja.pagadala599@gmail.com].
- For how long will this data be available start date provided 22-04-2024 and end date provided 22-04-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Subarachnoid block is a popular mode of anaesthesia for lower abdominal as well as lower limb surgeries. It is not associated with disadvantages of general anaesthesia like airway manipulation, usage of multiple drugs, additional supplementary analgesics, postoperative nausea and vomiting. Local anaesthetic drugs such Bupivacaine, Levobupivacaine and Ropivacaine are commonly used for spinal anaesthesia, with Bupivacaine being most common. The advantages being, early onset and prolonged duration of sensory blockade. Ropivacaine, a newer amide local anaesthetic has many similar properties with Bupivacaine, but with lesser incidence of cardiovascular and central nervous system toxicity. Ropivacaine also has a faster recovery from motor block. Adding adjuvants like Morphine, Fentanyl, Dexmedetomidine to the local anaesthetic increases the duration of action, increases the density of block, decreases the dose requirement thereby also reducing the risk of complications. Fentanyl and Morphine are known to cause side effects like nausea, vomiting and pruritus. Intrathecal Dexmedetomidine, an alpha 2 receptor agonist as an adjuvant had favourable outcomes. Addition of Dexmedetomidine to Ropivacaine and Bupivacaine for spinal anaesthesia in parturients has shown to hasten the onset of sensory and motor block, prolong the time of sensory block, improve muscle relaxation, improve intraoperative somatovisceral sensory block characteristics and postoperative analgesia, decrease shivering, with minimal hemodynamic and other side effects. There is paucity of literature comparing the effect of Dexmedetomidine as an adjuvant to Bupivacaine and Ropivacaine on block characteristics. Hence, the present study has been designed to compare the effects of Dexmedetomidine as an adjuvant with 0.5% hyperbaric Bupivacaine and 0.75% hyperbaric Ropivacaine on onset, duration and recovery from sensory and motor blockade in spinal anaesthesia and also on hemodynamic effect. |