| CTRI Number |
CTRI/2023/02/049684 [Registered on: 14/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two drugs used in spinal anaesthesia named as hyperbaric Levobupivacaine (fixed dose combination) and Fentanyl versus hyperbaric Levobupivacaine (reconstituted ) and Fentanyl in patients undergoing surgeries below level of umbilicus |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal anaesthesia with hyperbaric (0.5%)Levobupivacaine (FDC-fixed dose combination)with Fentanyl and hyperbaric (0.5%) Levobupivacaine (reconstituted )with Fentanyl in patients undergoing infra-umbilical surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TMU/IEC/2021-22/38 version 1 |
Protocol Number |
| U1111-1287-3920 (22/01/2023) |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Sharma |
| Designation |
Resident Doctor |
| Affiliation |
Teerthanker Mahaveer Medical college and reserch centre, Moradabad,Uttar pradesh |
| Address |
Room no 204, 2nd floor,
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9452038393 |
| Fax |
|
| Email |
officer.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G S Jheetay |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh |
| Address |
Room no 204, 2nd floor,
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Room no 204, 2nd floor,
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218770729 |
| Fax |
|
| Email |
drgurdeep.medical@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Jain |
| Designation |
Associate Professor |
| Affiliation |
Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh |
| Address |
Room no 204, 2nd floor,
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Room no 204, 2nd floor,
Department of Anaesthesia, Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh
Ambedaker Nagar
UTTAR PRADESH
244001
India |
| Phone |
9855567933 |
| Fax |
|
| Email |
payalravi1408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
| Address |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vivek sharma |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
Department of anaesthesia ,Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh
Moradabad
UTTAR PRADESH |
9452038393
officer.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, T.M.University, moradabad , uttar pradesh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S399||Unspecified injury of abdomen, lower back, pelvis and external genitals, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
hyperbaric (0.5%) Levobupivacaine (reconstituted )with Fentanyl |
intrathecal route spinal anaesthesia once given prior to surgery with hyperbaric (0.5%) Levobupivacaine 15 mg (3ml) plus dextrose 50 mg /ml(reconstituted )with Fentanyl 25 microgram in patients undergoing infra-umbilical surgeries
Duration of sensory block up to 480 min or 8 hrs. |
| Intervention |
hyperbaric (0.5%)Levobupivacaine (FDC-fixed dose combination)with Fantanyl |
Spinal anaesthesia given through intrathecal route given once before start of surgical procedure with hyperbaric
(0.5%)Levobupivacaine 15 mg (3ml) plus dextrose 80 mg /ml with Fentanyl 25 microgram in patients undergoing infra-umbilical surgeries.
Duration of sensory block up to 480 min or 8 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of the American Society of Anesthesiologists physical status I and II, scheduled to undergo infra-umbilical surgery under spinal anaesthesia will be select
Informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled hypertension, Neurologic disease, left ventricular dysfunction and coagulation Disorders.
Pregnancy
Hypersensitivity to amide local anesthetics
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following Primary outcome parameters are as follows :-
1. Onset of sensory block (min.)
2. Duration of sensory block (min.)
3. Onset time of motor block (min.)
4. Total duration of motor block (min.)
5. Duration of analgesia (min.)
|
1. Onset of sensory block (min.) -loss of sensation to T-8 level.
2. Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes.
3. Onset time of motor block (min.)
4. Total duration of motor block (min.)
5. Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia
Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamics (HR, RR, SBP, DBP, MAP, SP02)Vitals
|
will be monitored every 2 mins up to 15mins and thereafter every 5 mins until the completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
15/02/2023 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [officer.sharma@gmail.com].
- For how long will this data be available start date provided 10-12-2024 and end date provided 12-12-2029?
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
|
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Brief Summary
|
This study is planned in context that hyperbaric Levobupivacaine ( fixed dose combination) is recently introduced in clinical use and there are limited number of comparative clinical studies available to compare the sensory /motor block efficacy , hemodynamic profile and complication of fixed dose hyperbaric levobupivacaine vs fixed dose hyperbaric bupivacaine.
The primary limitation of earlier comparative studies is use of mixed dose hyperbaric Levobupivacaine because hyperbaric property is due to addition of dextrose in isobaric levobupivacaine.
so, the difference in the spinal charactiestics may have been in part related to the difference in baracity and dextrose concentration as well as constitution of hyperbaric solution..
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