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CTRI Number  CTRI/2021/05/033463 [Registered on: 07/05/2021] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparision of two adjuvant opioid drugs fentanyl and nalbuphine used for spinal anaesthesia in lower limb surgeries 
Scientific Title of Study   A comparative study to know the efficacy of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine for lower limb surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi N R 
Designation  Junior Resident in Anaesthesiology 
Affiliation  Shri B M Patil Medical College Hospital & Research Centre 
Address  Department of Anaesthesiology Shri B M Patil Medical College Bijapur

Bijapur
KARNATAKA
586103
India 
Phone  9986745669  
Fax    
Email  drswathinr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vijay V Katti 
Designation  Associate professor 
Affiliation  Shri B M Patil Medical College Hospital & Research Centre 
Address  Department of Anaesthesiology Shri B M Patil Medical College Bijapur

Bijapur
KARNATAKA
586103
India 
Phone  9844585900  
Fax    
Email  drvijaykatti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swathi N R 
Designation  Junior Resident in Anaesthesiology 
Affiliation  Shri B M Patil Medical College Hospital & Research Centre 
Address  Department of Anaesthesiology Shri B M Patil Medical College Bijapur

Bijapur
KARNATAKA
586103
India 
Phone  9844585900  
Fax    
Email  drswathinr@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical College Hospital  
 
Primary Sponsor  
Name  Shri B M Patil Medical College 
Address  Dept of Anaesthesiology Shri B M Patil Medical College Bijapur 586103 
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 
Swathi N R  Shri B M Patil Medical College   Department of Anaesthesiology, Bijapur-586103
Bijapur
KARNATAKA 
9986745669

drswathinr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrathecal injection of Fentanyl AND Nalbuphine  To study the effects of intathecal hyperbaric bupivacaine 0.5% with fentanyl versus hyperbaric bupivacaine 0.5% with nalbuphine in lower limb surgeries 
Comparator Agent  Nalbuphine and Fentanyl  Intrathecal route of administration. Dose- Bupivacaine 0.5% 3 ml with Nalbuphine 1mg compared with Bupivacaine 0.5% 3ml with Fentanyl 25mcg in each group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients aged between 18-60 years of both sex undergoing elective lower limb surgeries.
Patients belonging to ASA Grade І and ІІ. 
 
ExclusionCriteria 
Details  Infection at the site of injection.
Hypersensitivity to study drugs.
Coagulopathy or other bleeding diathesis.
Patients with peripheral neuropathy.
Patients with cardiac, pulmonary, hepatic or renal disorder.
Pregnancy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine.  At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the haemodynamic changes like heart rate and blood pressure, Time of rescue analgesia and Side effects of study drugs.
 
At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue 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   Phase 1/ Phase 2 
Date of First Enrollment (India)   17/05/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not sent for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

During preoperative visit patient’s detailed history, general physical examination and systemic examination will be carried out. History of any significant medical illness will be elicited. Airway, respiratory system and cardiovascular system will be assessed.

Only ASA grade І and ІІ patients within the age group of 18 to 60 years of either sex undergoing elective lower limb surgeries will be included in our study. A written informed consent will be taken.


Patient will be shifted to operation table, IV access will be obtained on forearm with 18 Gauge IV cannula and Ringer’s lactate solution 500ml will be infused intravenously before the block. The monitors will be connected to patient which include non-invasive blood pressure. Oxygen saturation using pulse oximeter.  Baseline PR, BP and SpO2 will be recorded.

      Under strict aseptic precautions, lumbar puncture will be performed in left lateral position by midline approach by using 26G Quincke spinal needle at L3-L4 intervertebral space and study drug will be injected intrathecally after confirming clear free flow of CSF. Patient’s vitals will be monitored continuously using mutli-parameter monitor. After spinal anaesthesia, Oxygen (5L/min) by facemask will be given, Fluid therapy will be maintained with Lactated Ringer’s solution (10ml/kg/hr).

 
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