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CTRI Number  CTRI/2024/12/077609 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of levobupivacaine Vs levobupivacaine with fentanyl given in the spinal space for blocking pain and sensation in lower abdomen and lower limbs surgeries 
Scientific Title of Study   Prospective Randomised Comparative Study Of Intrathechal Levobupivacaine And Levobupivacaine With Fentanyl In Infraumbilical Surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Juhi Atul Shah 
Designation  Postgraduate 
Affiliation  D Y Patil Hospital 
Address  A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  9004340652  
Fax    
Email  juhiashah20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Source of Monetary or Material Support  
A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra - 400706 India  
 
Primary Sponsor  
Name  D Y Patil Hospital 
Address  A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra - 400706 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJuhi Shah  D Y Patil Hospital  A block , second floor Department of Anesthesia Dr DY Patil Hospital Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra - 400706 India
Thane
MAHARASHTRA 		 9004340652

juhiashah20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine 0.75% hyperbaric  Dosage : 22.5 mg Route : Subarachnoid Volume : 3 ml Duration : till recovery of motor function 
Comparator Agent  Levobupivacine 0.75% Hyperbaric and Fentanyl 25mcg  Dosage : 22.5 mg + 25mcg Route : Subarachnoid Volume : 3.5 ml Duration : till recovery of motor function 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patient giving consent undergoing infraumbilical surgeries

Patients 18-60years

Patients of either sex

ASA grade I, II
 
 
ExclusionCriteria 
Details  Patients who are pregnant

Patients known or suspected to have allergy for study drug

Patients with any infection at the site of injection
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the time of onset and duration of sensory and motor block and to assess the time of recession of motor block.  Before induction
5mins , 10 mins , 15mins , 20 mins , 30 min,40mins,50 mins,60 mins and post-operative in the recovery room. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the intraoperative hemodynamic changes  Before induction
5mins , 10 mins , 15mins , 20 mins , 30 min,40mins,50 mins,60 mins till end of surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/12/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Levobupivacaine is a long acting local anaesthetic which produces differential neuraxial block that is early onset and prolonged duration of sensory block with the shorter duration of motor block and low cardiac toxcitiy. Intrathecal opioids enhance sensory block without prolonging motor and sympathetic block. The aim is to study the efficacy of intrathecal levobupivacaine versus levobupivacaine with fentanyl in infraumbilical surgeries .In the prospective clinical study,after approval from Institutional Ethical Committee and with informed written consent, patients of American Society of Anesthesiologists (ASA) class 1 or class 2 of either sex, between 18 to 60years undergoing elective lower umbilical surgeries will be recruited. After the injection of the spinal medication heart rate and arterial blood pressure will be measured,.motor and sensory block level will be assessed. Arterial pressure and heart rate will be recorded at 2min interval upto 20min and 10min intervals thereafter untill complete regression of the block.The assessments of sensory block done by pinprick test  and Results of the pinprick test were determined bilaterally at midclavicular level by using a short- beveled 27-gauge needle. Motor block in the lower limb was assessed by using a modified Bromage scale (0 - no paralysis, 1-unable to raise extended leg, 2-unable to flex knee, 3-unable to flex ankle). These assessments were performed immediately after the assessments of sensory block until the return of normal motor function. 
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