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CTRI Number  CTRI/2017/07/009057 [Registered on: 17/07/2017] Trial Registered Retrospectively
Last Modified On: 16/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Nalbuphine as an addition to Bupivacaine in Supraclavicular block for Upper Limb Orthopedic Surgeries. 
Scientific Title of Study   “Clinical evaluation of Nalbuphine as an adjuvant to local anaesthetic in Supra Clavicular Brachial Plexus Block for Upper Limb Orthopedic Surgeris: 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  Dr Harshali Bhavsar 
Designation  second year resident 
Affiliation  Govt. Medical College, Bhavnagar 
Address  Department of Anaesthesiology, Government Medical College And Sir Takhatsinhji Hospital,Bhavnagar.

Bhavnagar
GUJARAT
364001
India 
Phone  9913517989  
Fax    
Email  harshalibhavsar44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Komal Shah 
Designation  Assossiate Professor 
Affiliation  Govt. Medical College And Sir Takhtsinhji Hospital, Bhavnagar 
Address  Department Of Anaesthesiology, Government Medical College Sir Takhatsinhji Hospital, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9913517989  
Fax    
Email  shah.komal@rediff.com  
 
Details of Contact Person
Public Query
 
Name  Dr Komal Shah 
Designation  Assossiate Professor 
Affiliation  Govt. Medical College And Sir Takhtsinhji Hospital, Bhavnagar 
Address  Department of Anaesthesiology, Government Medical College And Sir Takhatsinhji Hospital, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9913517989  
Fax    
Email  shah.komal@rediff.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesiology, Govt. Medical College, Bhavnagar 
 
Primary Sponsor  
Name  Department of Anaesthesiology And Sir Takhatsinhji Hospital 
Address  Department Of Anaesthesiology, Government Medical College And Sir Takhatsinhji Hospital, Jail Road, Bhavnagar-364001 Gujarat 
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 Harshali Bhavsar  Government Medical College And Sir Takhatsinji Hospital, Bhavnagar  Department Of Anaesthsiology, Government Medical College And Sir Takhatsinhji Hospital, Jail Road, Bhavnagar 364001,
Bhavnagar
GUJARAT 
09913517989

harshalibhavsar44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee,Government Medical College, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients posted for upper limb orthopaedic surgery of 18 to 60 yrs of age belonging to ASA I and II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BUPIVACAINE, NORMAL SALINE  DOSE- BUPIVACAINE 25 ML NORMAL SALINE 5 ML FREQUENCY-SINGLE TIME ROUTE- SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK DURATION-24 HOURS AFTER BLOCK 
Intervention  Bupivaciane, nalbuphine  DOSE-Bupivacaine(0.5%)25 ml nalbuphine 20 mg DILUTED UPTO 5 ML OF NORMAL SALINE FREQUENCY-SINGLE TIME ROUTE- SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK DURATION-24 HOURS AFTER BLOCK 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Informed written consent for participation in study.
Gender: Either gender.
Patients scheduled for elective upper limb orthopedic surgery
ASA physical status I and II.
BMI ≤ 25kg/m2.
 
 
ExclusionCriteria 
Details  1.Patients refusing consent.
2.Contraindications to regional anesthesia:
Previous nerve injury.
History of drug dependence/abuse.
History of drug allergy.
Allergic to local anaesthetics.
Patients taking analgesics and sedatives.
Patients on anticoagulants.
History of bleeding disorders.
Psychiatric illness.
Uncooperative patients.
3.Any major systemic illness like hypertension, heart block etc.
4.Antenatal females and lactating mother.
5.Inadequate effect requiring supplementation.
6.ASA physical status III and above.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1.Onset, peak and duration
of sensory blockade.
2.Onset, peak and duration
of motor blockade.
3.Duration of effective
post-operative analgesia.
4.Total dose and frequency
of rescue analgesics
required in 24 hours.
5.Ramsey Sedation score. 
baseline and than 1 min,3 min,5 min,10 min,15
min,30 min, 1 hour,2 hour, 3 hour, 4 hour and
every 2 hourly till 24 hours after brachial block
Secondary 
 
Secondary Outcome  
Outcome  TimePoints 
1.Effects on hemodynamic
variables Heart Rate,
Mean Arterial Blood andperipheral oxygen
saturation. 
baseline and than 1 min,3 min,5 min,10 min,15
min,30 min, 1 hour,2 hour, 3 hour, 4 hour and
every 2 hourly till 24 hours after brachial block 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/02/2017 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After institutional review board approval (IRN NO: 631/2016) and written informed consent from patient, this prospective randomized double-blinded clinical trial is being carried out in 100 patients. After thorough preanaesthetic evaluation patients are allocated into two groups according to inclusion and exclusion criteria. Patients are randomized to one of the two groups of 50 patients each by computer generated random number sequence.

Group N (n = 50) – Bupivacaine(0.5%) 25 cc + Nalbuphine 20 mg diluted upto 5 ml of normal saline

Group C(n = 50) –  Bupivacaine(0.5%) 25 cc + 5 ml normal saline

In preanaesthetic preparation Room, standard monitoring for Heart Rate (ECG), Mean arterial blood pressure (NIBP), Peripheral oxygen saturation (SpO2) are established and baseline vital parameters are recorded. Patients are educated for subjective reporting of pain using 10 points visual analogue scale (VAS) where ‘0’ represents no pain and ‘10’ represented the worst pain possible. An appropriate size i.v. Cannula is secured and DNS infusion is started slowly. Injection Ondansetron 0.08 mg/kg is given as premedication 15 minutes before induction. In the preoperative preparation room only, patients are randomized to one of the two study groups by computer generated random number sequence. The doctor performing the randomization, prepared the solution as per the group assigned and no other member of the research team knows about the contents of the solution. In the operation theatre, we perform supraclavicular brachial plexus block with the aid of Nerve locator (B. BRAUN Company). After giving the position for supraclavicular brachial plexus block, a 22G short beveled 1.5 inch insulated needle is introduced just lateral to subclavian artery pulsation 1 cm above the mid-point of clavicle and advanced in backward, inward and downward direction. The current is initially set to deliver 0.5 milliamperes (mA) at 2Hz stimulation frequency. The needle is advanced till we get contraction of forearm muscle. Once the contraction is seen, current is reduced in 0.02 mA decrements while advancing the needle till we get maximum contraction with minimum possible current. At this point, the solution as per the group assigned is injected after careful aspiration so as to avoid intravascular injection of drug.The doctor performing the block is unaware of the drug combination administered. End of the injection is taken as Time ’0’. Immediately after the block, sensory and motor characteristics of blockade, hemodynamic variables, SpO2 are assessed by the same doctor who performs the block at 1, 3, 5, 10, 15, 30 minutes,1 hour, 2 hour, 3 hour, 4 hour and then at two hourly interval for 24 hours. Post operatively the time of first rescue analgesic required at visual analouge score 4 and total analgesic doses given in 24 hours are noted. Diclofenac sodium 1.5 mg/kg i.v. is given as rescue analgesic whenever required (VAS=4).Any complication or adverse event are also noted down. Bradycardia is defined as heart rate <60/min and is treated by inj. Atropine intravenously. Variation in mean arterial pressure 30% on either side of baseline is considered significant and treated accordingly.

 
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