| CTRI Number |
CTRI/2017/10/010087 [Registered on: 13/10/2017] Trial Registered Prospectively |
| Last Modified On: |
12/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare efficacy of bupivacaine (density more than csf)and levobupivacaine (density equal to csf) when given in subarachnoid space in cases of urological surgeries. |
|
Scientific Title of Study
|
A comparative study of intrathecal hyperbaric bupivacaine and isobaric levobupivacaine in urological surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
Indira Gandhi Institute of Medical Sciences, sheikhpura
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
Indira Gandhi Institute of Medical Sciences, sheikhpura
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrakant Prasad |
| Designation |
M.D. Student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
Indira Gandhi Institute of Medical Sciences, sheikhpura
Patna
BIHAR
800014
India |
| Phone |
9572598662 |
| Fax |
|
| Email |
chandrakant.rims07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14, Bihar, INDIA |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpura, Patna-14, Bihar |
| 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 |
| Dr Vinod Kumar Verma |
Indira Gandhi Institute of Medical sciences, Shekhpura |
Urology Operation theatre no. 1 and 4, PACU and urology ward
Patna
BIHAR |
9473191825
drvvinodv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Status 1 & 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine and isobaric Levobupivacaine |
Group A will be given 2.5 ml 0.5% hyperbaric bupivacaine while Group B will be given 2.5 ml isobaric levobupiovacaine. dose 12.5 mg each either drug, frequency only once before commencement of surgery, duration of therapy- monitoring 24 hours after surgery. |
| Intervention |
Subarachnoid block |
Subarachnoid block will be given in L3-L4 subarachnoid space using 26G whitacre spinal needle after confirming free flow of CSF. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing elective urological surgery under spinal anaesthesia.
2)Aged between 30-60 years.
3)ASA grade 1 & 2.
4)Those who are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1) persons with pre existing renal, cardiovascular,hepatic or other systemic diseases.
2)bleeding diathesis.
3)infection at the site of block
4)abnormalities of spine
5)Aspirin ingestion in preceeding week |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset, Duration, and level of motor and sensory block, motor and sensory regression period. |
time to reach t-9 sensory level will be taken as onset time.time to 1st rescue analgesic after surgery will give duration of analgesia. level of block will be assessed every 5 minutes till 30 minutes after block. motor and sensory regression will be assessed every 15 minutes post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse effect like nausea, vomiting, hypotension, bradycardia or breathing difficulty. |
hypotension, bradycardia will be assessed every 5 minutes intra-operatively and every 15 minutes post-operatively. other adverse effects will be recorded if occurs any time intra operatively and post operatively till the regression of sensory block. |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/10/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.CamorciaM,CapognaG,BerrittaC,ColumbMO.The relative potencies for motor block after intrathecalropivacaine,levobupivacaine and bupivacaine.AnesthAnalg 2007;104:904-07.
2. Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecalropivacaine, levobupivacaine and bupivacaine for caesarean section. Br J Anaesth 2003;91:684-89.
3. Bremerich DH, Kuschel S, Fetsch N, Zwissler B, ByhahnC,Meininger D: Levobupivacaine for parturients undergoing elective caesarean delivery. A dose-finding investigation Anaesthesist; 2007 Aug; 56(8):772-29.
4. Sen H1, Purtuloglu T, Sizlan A, Yanarates O, Ates F, Gundu I, Ozkan S, DagliG.Comparison of intrathecal hyperbaric and isobaric levobupivacaine in urological surgery.Minerva Anestesiol. 2010 Jan;76(1):24-8. Epub 2009 Nov 24.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After obtaining
ethical clearance 100 in-patients of Indira Gaandhi Institute of Medical
Sciences, Patna belonging to ASA I and II posted for elective urological
surgeries will be included in this study.
Pre-anaesthetic
checkup will be done for all patients and written informed consent will be
taken. On the day of surgery, patients will be shifted to the operation theatre
with an 18 G IV cannula secured and they
will be preloaded with Ringer Lactate 10ml/kg approximately 20 minutes prior to
the administration of spinal anaesthesia.
Non invasive
blood pressure monitor, pulse oximeter and ECG leads will be connected for all
patients and baseline values will be recorded. Supplementary oxygen will be
provided at the rate of 5 litres/min via a face mask.
Under strict
aseptic precautions 2.5ml of the study drug will be loaded by an
anaesthesiologist not involved in the study. Therefore, the patient and the
anaesthesiologist performing the spinal block and recording the intraoperative
and postoperative data will be blinded. The study drug will be injected into
L3-L4 sub arachnoid space using 26G whitacre spinal needle after confirming free
flow of cerebrospinal fluid and the time of injection will be recorded as 0
minutes. Following this the patients will be made to lie supine immediately .
Surgery will commence after loss of sensation to pinprick at T6 level.
Following
parameters will be noted:
Onset of sensory block–Time taken from injection of study drug ( 0 minutes
) to loss of sensation to pin-prick at T6 level. It will be tested using a
blunted 24G hypodermic needle bilaterally in the mid-clavicular line every 2
minutes.
Maximum sensory block attained– Time
taken from injection of study drug (0 minutes ) till the patient attains loss
of sensation at the highest dermatome in 10 minutes.It will be tested every 2
minutes using a blunted 24 g hypodermic needle bilaterally in mid-clavicular
line for the first 10 minutes.Time taken to reach the highest level of block
will be recorded.
Duration of sensory block– Time
taken from maximum block height attained till regression of block to T10
dermatome. It will be tested at the end of surgery using a 24G hypodermic
needle bilaterally in mid-clavicular line.
Onset of motor block–Time
taken from injection of study drug ( 0 minutes ) till the patient attains
Bromage 2.It will be tested using modified Bromage scale every 2 minutes.
Maximum motor block attained– Time
taken from injection of drug ( 0 minutes ) till the patient attains maximum
motor block.It will be tested every 2 minutes for the first 10 minutes.Time
taken to attain the maximum motor block score in 10 minutes will be recorded.
Duration of motor block– Time
taken from maximum Bromage score attained to Bromage 0.It will be tested at the
end of surgery using modified Bromage scale.
Hemodynamic
changes- Heart rate, systolic and mean arterial pressure and
oxygen saturation will be recorded every 5 minutes till the completion of
surgery and every 10 minutes postoperatively
till the regression of sensory and motor block.
|