CTRI Number |
CTRI/2023/02/049704 [Registered on: 14/02/2023] Trial Registered Prospectively |
Last Modified On: |
13/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison the efficacy of 0.5 % hyperbaric levobupivacaine with 0.5% levobupivacaine plus fentanyl in lower limb orthopaedics surgery under spinal anaesthesia. |
Scientific Title of Study
|
Comparison of 0.5% hyperbaric levobupivacaine with 0.5% hyperbaric levobupivacaine plus fentanyl in lower limb orthopaedic surgery under spinal anaesthesia. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR MANDAKINI KATIYAR |
Designation |
Postgraduate Resident |
Affiliation |
Peoples college of medical science and research centre bhopal. |
Address |
Department of anaesthesia peoples College of medical sciences and research centre.bhopal.
Bhopal MADHYA PRADESH 462037 India |
Phone |
09769422467 |
Fax |
|
Email |
mandakinikatiyar.23@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
dr sourabh jain |
Designation |
associate professor |
Affiliation |
peoples college of medical sciences and research center.bhanpur bhopal |
Address |
department of anaesthesia
Peoples college of medical sciences and research centre. bhopal MP
MADHYA PRADESH
462001
INDIA Department of anaesthesia.
Peoples college of medical sciences and research centre.bhopal Bhopal MADHYA PRADESH 462001 India |
Phone |
|
Fax |
|
Email |
ph.anaesthsia@peoplesuniversity.edu.in |
|
Details of Contact Person Public Query
|
Name |
DrMandakini katiyar |
Designation |
Postgraduate Resident |
Affiliation |
peoples college of medical sciences and research center bhanpur, bhopal |
Address |
Department of anaesthesia.
Peoples college of medical sciences and research centre. bhopal MP
BHOPAL
MADHYA PRADESH
462001
INDIA Department of anaesthesia.peoples college of medical sciences and research centre.bhopal Bhopal MADHYA PRADESH 462001 India |
Phone |
|
Fax |
|
Email |
mandakinikatiyar.23@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesia .peoples college of medical science and research centre,bhopal ( madhya pradesh ) .462037 |
|
Primary Sponsor
|
Name |
Mandakini katiyar |
Address |
Department of anaesthesia peoples medical college and research center. bhopal MP |
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 |
Mandakini katiyar |
Peoples college of medical science and research center |
Department of anaesthesia, peoples college of medical sciences and research center, bhopal MP Bhopal MADHYA PRADESH |
09769422467
mandakinikatiyar.23@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
peoples college of medical science and research center institutional ethics comittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
0.5% hyperbaric levobupivacaine |
levobupivacaine , a pure (-) enantiomer of racemic bupivacaine and has low cardiotoxicity and less undesired effects on central nervous system because of its significantly low side effects,levobupivacaine seems to be an attractive alternative to bupivacaine.it produces localized anaesthesia by blocking the transmission of action potential in sensory,motor,and sympathetic nerves fibers ,by inhibiting the passage of sodium through voltage sensitive ion channels in the neuronal membrane.the duration of drugs will be seen till drug effect weans off. |
Comparator Agent |
0.5%levobupivacaine plus fentanyl |
fentanyl is a potent synthetic opioid with a strong agonistic action at the mu opioid receptor with a rapid onset and short duration of action.fentanyl when added to local anaesthetic in spinal anaesthesia ,potentiates the action via central opioid receptor mediated analgesia by the peripheral uptake of fentanyl to the system circulation.opiates are widely known to have an analgesic effect at the central and spinal cord level.the effect will be seen till the drug effect weans off. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA GRADE 1 AND 2.
SCHEDULED FOR ELECTIVE LOWER LIMB ORTHOPAEDICS SURGERIES UNDER SPINAL ANAESTHESIA. |
|
ExclusionCriteria |
Details |
1. LACK OF PATIENTS CONSENT.
2. PATIENT REFUSALFOR SPINAL ANESTHESIA.
3.HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION ,CORONARY ARTERY,OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE.
4. PATIENTS WITH LOCAL SKIN SITE INFECTION.
5.PATIENTS WITH HYPERSENSTIVITY TO ANY OF THE DRUGS USED.
6.PREGNANT AND LACTATING MOTHERS. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
â—To study and compare the onset of analgesia, duration of sensory blockade , motor blockade, hemodynamics parameters ( SBP,DBP,MAP,HR) of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.
|
first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min. |
|
Secondary Outcome
|
Outcome |
TimePoints |
to compare the side effects of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.
|
first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min. |
|
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)
|
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
various clinical trials have found that administration of fentanyl with local anaesthetic in spinal anaesthesia prolonged the duration of sensory and motor blockade.
however ,there are limited data available on comparing of fentanyl as adjunvant to levobupivacaine in spinal anaesthesia.so we want to compare whether adding fentanyl tolevobupivacaine for spinal anaesthesia would affect the sensory and motor blocks and duration of analgesia.the present work has been undertaken to study and compare the effect provided by fentanyl as adjuvants to levobupivacaine in spinal anaesthesia. |