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CTRI Number  CTRI/2023/06/053700 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 07/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of injection nalbuphine as an adjuvant to injection bupivacaine for pain during post operative period 
Scientific Title of Study   To assess the efficacy of inj nalbuphine as an adjuvant to intrathecal bupivacaine anaesthetic in endoscopic urological surgeries for prolongation of post operative analgesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saiesh Raut Dessai 
Designation  Junior Resident 
Affiliation  Datta Medhe Institute of Higher Education And Research 
Address  Department of Anaesthesia, Room: NSB OT, Acharya Vinobha Bhave Hospital,Sawangi, Wardha
Sawangi
Wardha
MAHARASHTRA
442001
India 
Phone  8390716609  
Fax    
Email  saieshrautdessai4321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjot Ninave 
Designation  Professor 
Affiliation  Datta Medhe Institute of Higher Education And Research 
Address  Department of Anaesthesia, Room: NSB OT, Acharya Vinobha Bhave Hospital,Sawangi, Wardha
Sawangi
Wardha
MAHARASHTRA
442001
India 
Phone  9921213404  
Fax    
Email  Drsusann02@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Saiesh Raut Dessai 
Designation  Junior Resident 
Affiliation  Datta Medhe Institute of Higher Education And Research 
Address  Department of Anaesthesia, Room: NSB OT, Acharya Vinobha Bhave Hospital,Sawangi, Wardha
Sawangi
Wardha
MAHARASHTRA
442001
India 
Phone  8390716609  
Fax    
Email  saieshrautdessai4321@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Department of Anaesthesia, Room: NSB OT, Acharya Vinobha Bhave Hospital,Sawangi, Wardha 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi (Meghe), Wardha- 442107, Maharashtra, India. 
Type of Sponsor  Private medical college 
 
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 
Saiesh Raut Dessai  Jawaharlal Nehru Medical College  Department of Anesthesiology, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA 		 8390716609

saieshrautdessai4321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta meghe institute of medical sciences institutional ethics committee  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 
Comparator Agent  injection bupivacaine  Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics. a medication used to decrease feeling in a specific area. In nerve blocks, it is injected around a nerve that supplies the area, or into the spinal canals epidural space.It is available mixed with a small amount of epinephrine to increase the duration of its action.It typically begins working within 15 minutes and lasts for 2 to 8 hours 
Intervention  Injection NALBUPHINE   To cause analgesia, nalbuphine adheres to k receptors. Perioperative analgesia is also improved when administered as an adjuvant to bupivacaine. It is a hybrid which has both agonist and antagonist actions that increases and attenuates the effects of -opioids.Duration will be observed from time of onset of analgesia intra-operative to postoperative period ,which usually last for around 6-8 hours post-operative  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing urological surgeries,duration 1-3 hours.ASA I and II, MPC I and II 
 
ExclusionCriteria 
Details  Lack of valid consent,ASA grade III and IV, patient with neurological disorder,bleeding disorder,patients on anticoagulants,infection at block site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The addition of adjuvant 1.5 mg Nalbuphine prolongs the duration of post operative analgesia  post operative 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Compare effects on Hemodynamic parameters,onset and suration of sensory and motor block,side effects if any  2 hours post operative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   18/06/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of the study is to compare the efficacy of the addition of intrathecal injection nalbuphine as an adjucant Bupivacaine with intrathecal injection Bupivacaine alone for analgesia in endoscopic urological studies.  
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