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CTRI Number  CTRI/2024/11/076695 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to compare the effect of nalbuphine and fentanyl as an additive to Hyperbaric bupivacaine in Spinal anaesthesia to compare intra-OT hemodynamic response  
Scientific Title of Study   A COMPARATIVE STUDY BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.0 cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.0 CC WITH FENTANYL 25 MICROGRAM IN INFRAUMBILICAL SURGERIES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kartik H Sangam 
Designation  Resident Doctor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre 
Address  Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8767272524  
Fax    
Email  sangam2494@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kartik H Sangam 
Designation  Resident Doctor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre 
Address  Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8767272524  
Fax    
Email  sangam2494@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kartik H Sangam 
Designation  Resident Doctor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre 
Address  Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8767272524  
Fax    
Email  sangam2494@gmail.com  
 
Source of Monetary or Material Support  
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre 
Address  Waghodia, Pipariya, vadodara, Gujarat, india- 391760 
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 
Kartik H Sangam  Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre  Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT 		 08767272524

sangam2494@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 7||Osteopathic, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, (4) ICD-10 Condition: M872||Osteonecrosis due to previous trauma, (5) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (6) ICD-10 Condition: M228||Other disorders of patella,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IN. FENTANYL 25 MCG INTRATHECALLY  INJ. FENTANYL 25 MCG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC 
Comparator Agent  INJ. NALBUPHINE 0.4 MG INTRATHECALLY  INJ. NALBUPHINE O.4 MG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to sign the informed written consent.
Patients of ASA Grade I and II of either gender.
Under Spinal anaesthesia for elective BELOW UMBILICAL SURGERIES
Aged 18 - 60 years.
No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study. 
 
ExclusionCriteria 
Details  Patient refusal.
Patient not NIL by mouth.
History of seizure disorder.
Known allergy to trial drugs.
Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
ASA III, IV, V Patients.
Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases , known fetal abnormalities)
Pregnant females
Failed spinal anaesthesia converted to general anaesthesia
Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block to compare hemodynamic response in infraumbilical surgeries  baseline
0 Minute
2 Minutes
5 Minutes
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20 Minutes
30 Minutes
45 Minutes
60 Minutes
75 Minutes
90 Minutes
120 Minutes
150 Minutes
180 Minutes 
 
Secondary Outcome  
Outcome  TimePoints 
to compare duration of Post-operative analgesia in group fentanyl and group nalbuphine   post operative rescue anaglesia 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/11/2024 
Date of Study Completion (India) 20/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   THE PURPOSE OF THE STUDY IS TO COMPARE THE HEMODYNAMIC VARIABLE AND POST-OPERATIVE ANAGLESIA IN PATIENTS RECEIVING INTRA-THECAL NALBUPHINE AND FENTANYL AS AN ADDITIVE TO HYPERBARIC BUPIVACAINE IN BELOW UMBILICAL SURGRIES. 
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