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CTRI Number  CTRI/2019/08/020916 [Registered on: 26/08/2019] Trial Registered Prospectively
Last Modified On: 21/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of three different doses of nalbuphine which is added to to Intrathecal hyperbaric bupivacaine in patients undergoing knee joint surgeries. 
Scientific Title of Study   Comparision of three different doses of nalbuphine as adjuvant to intrathecal hyperbaric bupivacaine in knee joint surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRKUSUMANCHI RANJITHA 
Designation  postgraduate  
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of anesthesiology,KIMS hospital,bhubaneswar.

Khordha
ORISSA
751024
India 
Phone  9701604525  
Fax    
Email  kusumanchiranjitha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSaswati Das 
Designation  Assistant professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of anesthesiology,KIMS hospital,bhubaneswar.

Khordha
ORISSA
751024
India 
Phone  9910760328  
Fax    
Email  das.saswati12@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSaswati Das 
Designation  Assistant professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of anesthesiology,KIMS hospital,bhubaneswar.

Khordha
ORISSA
751024
India 
Phone  9910760328  
Fax    
Email  das.saswati12@gmail.com  
 
Source of Monetary or Material Support  
KUSUMANCHI RANJITHA 
 
Primary Sponsor  
Name  Kalinga institute of medical sciences 
Address  Kalinga institute of medical sciences,campus-5,KIIT road,Patia,Bhuabneswar,Odisha. 
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 
DrKUSUMANCHI RANJITHA  Kalinga institute of medical sciences  Operation theatre complex-3rd floor,Department of anesthesiology.
Khordha
ORISSA 		 9701604525

kusumanchiranjitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M239||Unspecified internal derangement of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nalbuphine  patient will receive 0.4mg nalbuphine diluted with normal saline to make it 0.5ml and added to 2.5ml 0.5%hyperbaric bupivacaine,Route- Intrathecally 
Comparator Agent  Nalbuphine  patient will receive 0.8mg nalbuphine diluted with normal saline to make it 0.5ml and added to 2.5ml 0.5%hyperbarice bupivacaine,Route-Intrathecally 
Comparator Agent  Nalbuphine  patient will receive 1.2mg nalbuphine diluted with normal saline to make it 0.5ml and added to 2.5ml 0.5%hyperbaric bupivacaine,Route-Intrathecally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of anesthesiologists (ASA) Physical status I and II,patient posted for surgery of knee joint. 
 
ExclusionCriteria 
Details  ASA PH III and IV,Height<150cm,BMI>30,Contraindication to spinal anesthesia,H/o adverse reactions to opioids,pregnancy. 
 
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 
To determine the optimum dose of nalbuphine with maximum analgesic and minimal side-effects.  Asessed every 15mins postoperatively till the patient receives first dose of rescue analgesia. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of onset and regression of snsory and motor blockade.  sennsory and motor status will be checked every 2 minutes after spinal injection for first 10 minutes,every 5 minutes for next 30 minutes,and 15mins till regression. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2 
Date of First Enrollment (India)   05/09/2019 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Spinal anesthesia is most commonly used technique  for lower limb surgries as it is very economical and easy to administer .However,postoperative pain control is a major concern because spinal anesthesia using only local anesthetics is associated with relatively shorter duration of action and thus early analgesic intervention is needed in postoperative period.
Various adjuvants are used to improve quality,prolong the duration of neuronal blockade and postoperative analgesia.
Nalbuphine is a  semi-synthetic opioid used as an adjuvant to sub-arachnoid blockade.
The main purpose of this study is to compare three different doses of nalbuphine and determine the optimum dose with maximum analgesic effect and mininal side-effects. 
 
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