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CTRI Number  CTRI/2020/06/025889 [Registered on: 15/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Giving block in the shoulder region to provide better and prolonged pain relief  
Scientific Title of Study   Comparison of Anaesthetic efficacy of Ropivacaine and Ropivacaine with Nalbuphine as an adjuvant for Ultrasound guided Supraclavicular Brachial plexus blockade: A Randomized Controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Arish RC/19/52 17/5/2019  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arish 
Designation  Assistant Professor, Department Of Anaesthesia  
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Arish Department Of Anaesthesia No 34, Main Road Kombakkam Pondicherry
Arish Department Of Anaesthesia Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry
PONDICHERRY
605110
India 
Phone  9791853400  
Fax    
Email  thebeast11.bt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arish 
Designation  Assistant professor, Department Of Anaesthesia  
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Arish Department Of Anaesthesia No 34 Main Road Kombakkam Pondicherry
Arish Department Of Anaesthesia Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry
PONDICHERRY
605110
India 
Phone  9791853400  
Fax    
Email  thebeast11.bt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arish 
Designation  Assistant Professor, Department Of Anaesthesia  
Affiliation  Pondicherry Institute Of Medical Sciences  
Address  Arish Department Of Anaesthesia No 34 Main road Kombakkam pondicherry
Arish Department Of Anaesthesia Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry
PONDICHERRY
605110
India 
Phone  9791853400  
Fax    
Email  thebeast11.bt@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pondicherry Institute of medical science 
Address  Kalathumettupathai, Ganapathichettikulam,Village No 20 Kalapet, Puducherry - 605014, 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 
Arish  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES   Department Of Anaesthesia 2nd Floor Emergency Building Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry
PONDICHERRY 
9791853400

thebeast11.bt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA I & ASA II undergoing elective upper limb surgeries  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ropivacaine and saline  Injection Ropivacaine of 2ml/kg with 1 ml of saline will be given in supraclavicular brachial plexus block under ultrasound guided technique 
Intervention  ropivacaine with nalbuphine  Injection Ropivacaine of 2ml/kg and 10mg of nalbuphine will be given in supraclavicular brachial plexus block under ultrasound guided technique 
 
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 To II Of Both Gender
Age Between 18 And 60 Years
Body Mass Index (BMI) <25 Kg/M2
Elective forearm and hand surgeries in orthopedic and plastic surgeries
 
 
ExclusionCriteria 
Details  Allergy to local anesthetics or Nalbuphine
Infection at the injection site
Patients with clinically significant coagulopathy
Preexisting neuromuscular disorders
Severe cardiovascular, or pulmonary disease, renal or hepatic disorder
Pregnancy and lactation
Patients taking medications with opioid or receiving chronic analgesic therapy other than simple analgesics were excluded from the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia between ropivacaine and ropivacaine with nalbuphine for supraclavicular brachial plexus blockade  after complete sensory blockade 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the onset of sensory and motor blockade and
To measure the duration motor blockade between the two study groups
To measure the amount of rescue analgesia requirement in the first 24 hours
To measure the hemodynamic changes during the procedure  
after complete sensory and motor blockade till first resue analgesia 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/06/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ropivacaine is a long-acting regional anesthetic that is structurally related to bupivacaine. It is a S(−) enantiomer, unlike bupivacaine, which is a racemate and  well-established long-acting regional anesthetic, which like all amide anesthetics has been associated with cardiotoxicity when used in high concentration or when accidentally administered intravascularly. Hence ropivacaine was developed for the purpose of reducing potential toxicity and improving relative sensory and motor block profiles. Various adjuvants have been added to local anesthetics in brachial plexus block to achieve quick, dense, and prolonged block; however, the results are either inconclusive or associated with side effects.

Nalbuphine, a derivative of 14-hydroxymorphine, is an agonist-antagonist opioid acting on µ (mu) receptors as antagonist and κ (kappa) receptors as agonist with an analgesic potency equal to morphine and its antagonistic potency is approximately ¼th of that of naloxone. Unlike morphine, it exhibits a ceiling effect on respiratory depression. Nalbuphine has the potential to maintain or even enhance µ-opioid-based analgesia while simultaneously mitigating the µ-opioid side effects. Therefore the purpose of this study is to compare by adding nalbuphine with ropivacaine in supraclavicular brachial plexus block and to know its efficacy.

 
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