CTRI Number |
CTRI/2023/01/048724 [Registered on: 04/01/2023] Trial Registered Prospectively |
Last Modified On: |
03/01/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare effect of two different local anaesthetic drugs given through spinal anaesthesia |
Scientific Title of Study
|
TO COMPARE BLOCK CHARACTERISTICS OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE WITH FENTANYL VERSUS INTRATHECAL HYPERBARIC BUPIVACAINE WITH FENTANYL IN UROLOGICAL SURGERIES: A Randomized Double-Blind Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vikash Kumar |
Designation |
Junior Resident 1 |
Affiliation |
Indira Gandhi Institute Of Medical Sciences |
Address |
Anaesthesia Dept ,first floor, IGIMS , Sheikhpura , Patna
Patna BIHAR 800014 India |
Phone |
8409697069 |
Fax |
|
Email |
vkskmc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mumtaz Hussain |
Designation |
Additional Professor |
Affiliation |
Indira Gandhi Institute Of Medical Sciences |
Address |
Anaesthesia Dept, first floor, IGIMS, Sheikhpura, Patna
Patna BIHAR 800014 India |
Phone |
9473376853 |
Fax |
|
Email |
drhussain72@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Mumtaz Hussain |
Designation |
Additional Professor |
Affiliation |
Indira Gandhi Institute Of Medical Sciences |
Address |
Anaesthesia Dept, first floor, IGIMS, Sheikhpura, Patna
Patna BIHAR 800014 India |
Phone |
9473376853 |
Fax |
|
Email |
drhussain72@yahoo.co.in |
|
Source of Monetary or Material Support
|
Vikash Kumar, Anaesthesia Dept ,first floor, IGIMS , Sheikhpura , Patna
Patna
BIHAR
800014
India |
|
Primary Sponsor
|
Name |
Vikash Kumar |
Address |
Anaesthesia Dept, first floor,IGIMS, Sheikhpura, Patna |
Type of Sponsor |
Other [Self] |
|
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 |
Vikash Kumar |
Urology operation theatre of IGIMS, Patna |
Urology OT , first floor, IGIMS, Sheikhpura, Patna Patna BIHAR |
8409697069
vkskmc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Hyperbaric bupivacaine and fentanyl |
Hyperbaric bupivacaine at 12.5mg with fentanyl at 25mcg in subarachanoid space by spinal needle after regular backflow of csf |
Intervention |
Hyperbaric Levobupivacaine and fentanyl |
Hyperbaric levobupivacaine at 12.5mg with fentanyl at25mcg with spinal needle in subarachnoid space after regular backflow of csf |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Patients of ASA physical status 1, 2
Patients able to comprehend and willing to participate.
Patients scheduled for general elective surgeries
|
|
ExclusionCriteria |
Details |
Patients who refuse to participate
Patients allergic to levobupivacaine and/or bupivacaine
Patients having infection at drug administration site
Patient having coagulopathy
Patient having pre existing neurological condition
Raised intracranial pressure
Any other absolute contraindication to spinal anaesthesia
Uncooperative patients
Body weight above 100 kg |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the block characteristics in regard of onset and duration of sensory and motor blockade between two group
|
Upto 3hours
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the hemodynamic parameters and adverse effects between them |
24hours postoperative |
|
Target Sample Size
|
Total Sample Size="176" Sample Size from India="176"
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 4 |
Date of First Enrollment (India)
|
05/01/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Planning to publish after completion of thesis |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Patients will be randomised 1:1 using sealed envelope technique into two groups of 88 each and study drug will be prepared by an anaesthesiologist not involved in the study. Group A (n=88) will receive 12.5mg (2.5 ml) of 0.5% hyperbaric levobupivacaine and fentanyl 25 mcg (0.5 ml) while Group B (n=88) will receive 12.5mg (2.5 ml) of 0.5% hyperbaric bupivacaine and fentanyl 25 mcg (0.5 ml). Thorough pre�’anesthesia check�’up will be done a day prior to surgery that is, detailed history, general physical examination, systemic examination, airway assessment and lumbar spine examination. Patients will be kept nil by mouth 6 hours for light meal and 2 hours for clear fluids before surgery. The anaesthesia plan will be explained to the patients. No premedication will be administered. Hemodynamic parameters will be recorded with ECG, systolic and diastolic blood pressure, heart rate and oxygen saturation (SpO2). Intravenous prehydration with 500 ml of 0.9% isotonic NaCl infusion will be administered. Hypotension, defined as a decrease of systolic blood pressure more than 20% from baseline or a fall below 90 mmHg, will be treated with intravenous doses of 3mg of ephedrine and intravenous fluid as required, and bradycardia, defined as heart rate below 50 beats/min, will be treated with 0.3–0.6mg of intravenous atropine. Patients will be placed on the operation table in the sitting position and will be administered 3 ml (60mg) 2% lidocaine infiltration anesthesia through L3–4 after sterilization with antiseptic solution (povidone iodine). The intrathecal space will be reached with a standard Quincke spinal needle of appropriate size. Non traumatic pin prick in the mid clavicular line with a blunt needle will be used for sensorial block evaluation (onset, offset) and sensorial block reversal time. Bromage scale will be used for assessment of the intensity of motor block. In the Bromage scale, the intensity of motor block is assessed by the patient’s ability to move their lower extremities as follows: 0=free movement of legs and feet; 1=just able to flex knees with free movement of feet; 2=unable to flex knees, but with free movement of feet; and 3=unable to move legs or feet. Onset of motor block is recorded as when Bromage scale is ‘1’ after administration of local anesthetics, and ‘onset of highest motor block’ is recorded as time to reach the highest scale of motor block that is Bromage scale 3. ‘Operation duration’ is recorded as time until end of operation after administration of local anesthetics. The hemodynamic parameters [systolic, diastolic blood pressure, mean blood pressure, heart rate and oxygen saturation (SpO2)] were recorded at 0 and every 10 min after injection of local anaesthesia. Side effects like hypotension, bradycardia, shivering, nausea and vomiting will be followed-up 24 hour postoperatively. |