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CTRI Number  CTRI/2023/07/055741 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 08/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of nalbuphine drug as an additive with 0.5 percent levobupivacaine for upper limb orthopedic surgery in ultrasound guided supraclavicular block. 
Scientific Title of Study   Study on the effect of nalbuphine as an adjuvant to 0.5% levobupivacaine in ultrasound guided supraclavicular Brachial Plexus Block  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhinav Gupta 
Designation  Post Graduate Resident 
Affiliation  School of Medical Science And Research 
Address  Department of Anesthesiology School of Medical Science And Research and Sharda hospital, Greater Noida
Room no: 411 P.G Hostel Sharda University ,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8884184078  
Fax    
Email  abhinav.gupta1@sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harsh Vardhan 
Designation  Professor 
Affiliation  School of Medical Science And Research 
Address  Department of Anesthesiology School of Medical Science And Research and Sharda hospital, Greater Noida
D-304 ,Prateek Laurel,sector-120, Noida -201301
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9871952687  
Fax    
Email  Harsh.vardhan1@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Harsh Vardhan 
Designation  Professor 
Affiliation  School of Medical Science And Research 
Address  Department of Anesthesiology School of Medical Science And Research and Sharda hospital, Greater Noida
D-304 ,Prateek Laurel,Sector-120,Noida -201301
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9871952687  
Fax    
Email  Harsh.vardhan1@sharda.ac.in  
 
Source of Monetary or Material Support  
School of Medical Science And Research And Sharda Hospital, Greater Noida 
 
Primary Sponsor  
Name  School of Medical Science And Research And Sharda Hospital, Greater Noida 
Address  Knowledge Park III Sharda University , Greater Noida 
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 
Dr Abhinav Gupta  School of Medical Science And Research And Sharda Hospital, Greater Noida  O.T Complex,2nd floor Department of Anesthesiology School of Medical Science And Research ,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
8884184078

abhinav.gupta1@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee School Of Medical Sciences And Research, Sharda University, Greater Noida  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  Normal saline added to 0.5% Levobupivacaine in ultrasound guided supraclavicular Brachial Plexus Block  Ultrasound Guided Supraclavicular Brachial Plexus Block will be given using normal saline 1ml added to 0.5% levobupivacaine 20 ml and assessment of pain ,sensory and motor block will be done for 24 hours 
Intervention  Nalbuphine added to 0.5% levobupivacaine in Ultrasound Guided Supraclavicular brachial plexus Block   Ultrasound Guided Supraclavicular Brachial Block will be given using nalbuphine 1mg(1 ml) added to 0.5% levobupivacaine 20 ml and assessment of pain ,sensory and motor block will be done for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective upper limb surgery.
2. Age between 18 to 65 years.
3. ASA physical status class 1 and 2
 
 
ExclusionCriteria 
Details  1. Patients with a history of allergy or hypersensitivity to either local anaesthetic or opioid drugs.
2. Pregnancy
3. Patients with coagulation disorders
4. Local infection at the site of injection
5. Patients who are taking any antipsychotics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesic effect in two groups.   24 hours  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. To compare onset & duration of block in the two groups.
(a) onset & duration of sensory block
(b) onset & duration of motor block
2. To compare the rescue analgesic requirements in the two groups.
3. To compare the incidence of side effects & to observe the incidence of complication in the two groups.
 
24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   04/08/2023 
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="6"
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  

Brachial plexus block is the most widely used approach for upper limb surgeries as an alternative to and in combination with general anaesthesia to achieve ideal operating conditions by providing adequate muscle relaxation, maintaining intraoperative hemodynamic stability, and sympathetic block. This block also reduces postoperative pain and the requirement for rescue analgesia.  A variety of approaches to brachial plexus have been described- inter scalene, supraclavicular, infraclavicular, and axillary. The supraclavicular block is the easiest to perform.The supraclavicular approach of the brachial plexus is the most common and effective block for most of upper limb surgeries. The supraclavicular approach blocks the brachial plexus at the level of distal trunks. The compact arrangement of structures at this site results in the rapid onset of dense and reliable blockade of the brachial plexus. The success of brachial plexus block relies on nerve localisation , needle placement and deposition of local anaesthesia solution at the right place by a single injection of local anaesthetic.The conventional blind technique relies on surface landmarks before needle insertion and elicitation of paresthesia while ultrasound guidance achieves excellent brachial plexus localization, accurate needle placement, and monitoring of drug spread in the appropriate tissue planes with painless performance. Ultrasound increases the success rate and reduces the injury to an adjacent structure. It also minimized the local anaesthethic volume, thereby reducing the incidence of their systemic toxicityUltrasound-guided supraclavicular brachial plexus block has improved the success rate of the block with excellent localization as well as an improved safety margin. By paraesthesia/ peripheral nerve stimulator technique, there is a risk of injury to surrounding structures, especially vascular structures and pleura.Local anaesthetics alone for supraclavicular brachial plexus block provide good operative conditions but have a shorter duration of postoperative analgesia. Hence, various adjuvants such as opioids,  clonidine, neostigmine, dexamethasone,  midazolam, and magnesium have been added to local anaesthetics in brachial plexus block to achieve quick, dense, and prolonged block. However, many are associated with side effects.Levobupivacaine, the S’enantiomer of bupivacaine, is a comparatively newer local anaesthetic agent acting on voltage dependent Na+ channels, introduced into clinical practice. It also possesses fewer cardiac and neural toxicities. Levobupivacaine is safe and effective for epidural and spinal anaesthesia and blockade of the brachial plexus

     Nalbuphine, derivative of 14 hydroxymorphine, is an agonist antagonist opioid acting on μ (mu) receptors as an antagonist and κ (kappa) receptors as an 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 can potentially maintain or even enhance μ opioid  based analgesia while simultaneously mitigating the μ’opioid side effects. .When nalbuphine given by intravenous route has  onset of action between 2 and 3 min  and a duration of action of 3–6 hrs with cardiovascular stability and minimal side effects in the dose of 0.2–0.4 mg/kg.  Nalbuphine can be used for pain management in children with burns and neoplastic or haematological diseases due to its safety profile.   Freedom from controlled drug act regulations and improved analgesia with nalbuphine render it more satisfactory for day care surgery than other commonly used opioidsSearch for the suitable adjuvant with local anaesthetics involve use of an agent which provide a quick onset of action and prolong the duration of action and less requirement of analgesia .These attribute should be accompanied with little or no side effects with this in mind this study is being conducted with nalbuphine as an adjuvant to 0.5% levobupivacaine.Therefore, our current study is aimed to assess the clinical efficacy and safety of nalbuphine as an adjuvant to 0.5% levobupivacaine for the supraclavicular block using ultrasound-guided techniques for various forearm and hand surgery.                                           

 
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