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CTRI Number  CTRI/2025/09/095115 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   comparing two medications with local anesthetic for pain relief in patients undergoing upper limb surgeries with help of ultrasound for nerve block.  
Scientific Title of Study   Comparative study of nalbuphine and clonidine as an adjuvant to ropivacaine in ultrasound guided supraclavicular brachial plexus block: a prospective randomised study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshitha G  
Designation  Junior Resident 
Affiliation  Sapthagiri Institute of Medical Sciences And Research Centre 
Address  Anesthesia Department,Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre,Navy Layout,Hesarghatta Main Road,Chikkabanavara,Bengaluru

Bangalore
KARNATAKA
560090
India 
Phone  8296539340  
Fax    
Email  harshug999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vinod Basappa Hosalli 
Designation  Professor 
Affiliation  Sapthagiri Institute of Medical Sciences And Research Centre 
Address  Anesthesia Department,Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre,Navy Layout,Hesarghatta Main Road,Chikkabanavara,Bengaluru

Bangalore
KARNATAKA
560090
India 
Phone  8310268837  
Fax    
Email  vinodhosallidr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinod Basappa Hosalli 
Designation  Professor 
Affiliation  Sapthagiri Institute of Medical Sciences And Research Centre 
Address  Anesthesia Department,Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre,Navy Layout,Hesarghatta Main Road,Chikkabanavara,Bengaluru

Bangalore
KARNATAKA
560090
India 
Phone  8310268837  
Fax    
Email  vinodhosallidr@gmail.com  
 
Source of Monetary or Material Support  
Sapthagiri institute of medical sciences and research Centre, no 15,chikkasandra, hesarghatta main road, Bengaluru- 560090. India. 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Sciences And Research centre 
Address  Navy Layout,Hesarghatta Main Road,Chikkabanavara 
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 Harshitha G  Sapthagiri Institute of Medical Sciences and Research Centre  Department of Anaesthesiology,Ground floor OT Complex,No 15,Hesarghatta Main Road, Chikkabanavara,Bangalore
Bangalore
KARNATAKA 		 8296539340

harshug999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sapthagiri institute of medical sciences and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  Patients allocated into Group C will receive 75 microgram of clonidine as an adjuvant to Ropivacaine in ultrasound guided supraclavicular brachial plexus block. 
Comparator Agent  Nalbuphine  Patients allocated into Group N will receive 10 milligram of Nalbuphine as an adjuvant to 0.5 percent Ropivacaine for ultrasound guided supraclavicular brachial plexus block. 
Intervention  Ultrasound guided supraclavicular brachial plexus block  Patients in supine position, with slight elevation of the head-end of the bed with the patient’s head turned away from the side to be blocked. Using aseptic technique, the probe will be positioned in the transverse plane immediately superior to the midpoint of the clavicle. under aseptic precautions Ultrasound guided supraclavicular brachial plexus block will be performed. Using 22G needle, Patients will be allocated to one of the two groups, Group N will receive 30 ml of 0.5 percent Ropivacaine with 10 milligram of Nalbuphine Group C will receive 30 ml of 0.5 percent Ropivacaine with Clonidine 75 microgram. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient willing to give informed consent
2.Age between 18-60 years
3.ASA ( American society of Anesthesiologist) physical status I and II
4.Patients undergoing upper limb surgery and planned for supraclavicular brachial block. 
 
ExclusionCriteria 
Details  1.Patients with diabetes, peripheral vascular diseases, neurological, cardiopulmonary or
psychiatric diseases
2.Allergy to study medications.
3.Local infections, Bleeding disorders.
4.Pregnant women and lactating mother.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.onset of sensory and motor blockade
2.duration of sensory and motor blockade
3.duration of post-operative analgesia 		 every 5min for first 30min thereafter every 10 min till end of surgery.
Post-operatively, sensory and motor blockade and vital parameters will be noted at
10min,30min and 1,2,4,6 and 12 hour after the end of surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   Phase 2 
Date of First Enrollment (India)   29/09/2025 
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   Patients fulfilling the inclusion criteria and posted for upper limb surgeries will be assigned to either group N and group C through a computer-generated sequence of random numbers, maintaining a equal ratio. Patients will be allocated to one of the two groups, Group N will receive 30 ml of 0.5 percent Ropivacaine with 10mg Nalbuphine and Group C will receive 30 ml of 0.5 percent Ropivacaine with Clonidine 75 microgram. Under Ultrasound guidance brachial plexus block will be given, onset of sensory and motor block will be noted. Duration of sensory and motor block will be assessed every 5min for first 30min thereafter every 10 min till end of surgery. Post-operatively, sensory and motor blockade and vital parameters will be noted at 10min,30min and 1,2,4,6 and 12 hour after the end of surgery. The block will be considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve did not have analgesia even after 30min of drug injection. Then such patients will be converted to general anaesthesia and will be excluded from the study.
There is limited literature available comparing nalbuphine and clonidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block. Hence, the present study will be undertaken to compare the efficacy of nalbuphine and clonidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block in terms of onset and duration of sensory and motor block and duration of post operative analgesia.
 
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