FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025082 [Registered on: 08/05/2020] Trial Registered Prospectively
Last Modified On: 06/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effect of two different types of drugs when mixed to the local anaesthetics for upper limb block  
Scientific Title of Study   A comparative study of the effect of Dexmedetomidine and Nalbuphine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block: A prospective randomized, double blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Mala 
Designation  Senior Resident 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE 
Address  Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  9955882635  
Fax    
Email  drmalajyoti17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyoti Mala 
Designation  Senior Resident 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE 
Address  Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  9955882635  
Fax    
Email  drmalajyoti17@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jyoti Mala 
Designation  Senior Resident 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE 
Address  Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  9955882635  
Fax    
Email  drmalajyoti17@gmail.com  
 
Source of Monetary or Material Support  
Jyoti Mala, Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna PIN- 800014 
 
Primary Sponsor  
Name  Jyoti Mala 
Address  C/O - Dr. Jyoti Mala, Senior Resident, Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna, PIN- 800014 
Type of Sponsor  Government 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 Arvind Kumar  Indira Gandhi Institute of Medical Sciences  Department of Orthopediocs and Surgery, Ward, Bed no 1-70, IGIMS, Patna
Patna
BIHAR 
9534870908

arvind007kumar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Medical Sciences Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of Dexmedetomidine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block  One group will receive 20 ml of 0.5% levobupivacaine with 1 μg/kg dexmedetomidine diluted to the volume of 10 ml NS, making total volume of 30ml. Ultrasound guided supraclavicular plexus block will be performed by placing the patient in the supine position with their head turned in the direction opposite the interventional side. Subsequently, the probe of the ultrasound equipment wrapped in sterile cover will placed on supraclavicular fossa to locate the subclavian artery and brachial plexus cluster. After local anesthetic infiltration, a 50 mm 22 G insulated short beveled stimulation needle will be inserted towards the brachial plexus cluster from lateral to medial in the long axis of the ultrasound beam after locating the subclavian artery and brachial plexus cluster. Once the needle tip reached the brachial plexus cluster on the ultrasound image,30 ml of drug will be injected as appropriate for the group of study.  
Intervention  Effect of Nalbuphine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block  Another group will receive 20 ml of 0.5% levobupivacaine with 1ml(10mg)of Nalbuphine diluted to the volume of 10 ml NS making total volume of 30ml. Ultrasound guided supraclavicular plexus block will be performed as mentioned above and 30 ml of drug will be injected as appropriate for the group of study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients posted for upper limb surgery of either side
2. Patients of ASA physical status 1 & 2
3. Patients between 18-50 years of age of either sex
4. Patients able to comprehend and willing to participate
 
 
ExclusionCriteria 
Details  1. Patient’s refusal to participate
2. Patients of ASA physical status3 & 4
3. Any allergy to local anaesthetics
4. Coagulation disorders
5. Infection at the site of intervention
6. History of any underlying cardiac, renal or hepatic dysfunction
•Pregnant patient
 
 
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 
1. Onset of motor block
2. Onset of sensory block
3. Duration of analgesia
 
3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamic stability
2. Side effects
 
3 months 
 
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   Phase 3 
Date of First Enrollment (India)   11/05/2020 
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="0"
Months="3"
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  

Supraclavicular brachial plexus blockade  is the common approach to provide surgical anesthesia of upper limb, was first described by Kulenkampff in 1911.(1) It is an efficient regional anesthetic technique for upper limb surgeries. Which is a reliable, alternative to general anesthesia for certain group of patients as it is devoid of undesired effects of general anesthesia and stress of laryngoscopy. The postoperative period is also free from pain, nausea, vomiting, and respiratory depression. Adjuvants are added to local anaesthetics to improve various block characteristics in terms of onset of action ,duration of analgesia with lesser adverse effect. Various study has been done using different types of adjuvants in different combination of local anaesthetics for various nerve blocks. In our study we will use levobupivacaine LA because it is relatively safe in terms of less cardiac and neurotoxic adverse effects. Dexmedetomidine is a highly selective an alpha 2 agonist which, when used as an adjuvant , prolongs the duration of action  without causing respiratory depression. Nalbuphine is recently introduced opioid agonist-antagonist. Unlike other opioids it has got ceiling effect. Furthermore,use  of ultrasound (US) has significantly improved the quality of nerve blocks by direct visualization of nerves and related anatomical structures, needle trajectory and spread of local anesthetics (LAs) during injection [2-7]. In addition, US guidance increases success rate, minimizes LAs volume needed for effective nerve block, and avoids potential complications such as intraneural or intravascular injection [2,4,5]. In this study, we plan to compare the efficacy of dexmedetomidine and nalbuphine as an adjuvant to levobupivacaine in ultrasound guided supraclavicular brachial plexus block.


 
Close