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CTRI Number  CTRI/2024/02/063359 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the pharmacological and physical effects of adding Fentanyl as an adjuvant to hyperbaric Bupivacaine in spinal anesthesia. 
Scientific Title of Study   Enhancing spinal anesthesia with intrathecal injection of Fentanyl as adjuvant to hyperbaric Bupivacaine. Pharmacological or physical effect? A randomized controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LIPIKA SAXENA 
Designation  post graduate resident 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur, rajasthan 
Address  main OT complex, 2nd floor, mahatma gandhi Hospital
Room No 322, 4-C hostel, Mahatma Gandhi Hospital campus, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India 
Phone  9717728035  
Fax    
Email  dr.lipikasaxena@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avnish Bharadwaj 
Designation  Professor and Head of department 
Affiliation  Mahatma Gandhi University Of Medical Sciences and technology 
Address  Department of anesthesia, Mahatma Gandhi Hospital

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  avnishbharadwaj1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avnish Bharadwaj 
Designation  Professor and Head of department 
Affiliation  Mahatma Gandhi University Of Medical Sciences and technology 
Address  Department of anesthesia, Mahatma Gandhi Hospital

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  avnishbharadwaj1@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi University of medical sciences and technology, RICCO industrial area, Jaipur, Rajasthan 302022 
 
Primary Sponsor  
Name  Mahatma Gandhi University of medical sciences and technology 
Address  sitapura, Jaipur, Rajasthan, 302022 
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 Avnish Bharadwaj  Mahatma Gandhi cHospital  OT complex, Head of department room, 2nd floor main Hospital building
Jaipur
RAJASTHAN 		 9314882845

avnishbharadwaj1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K389||Disease of appendix, unspecified, (2) ICD-10 Condition: K389||Disease of appendix, unspecified, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K37||Unspecified appendicitis, (5) ICD-10 Condition: K37||Unspecified appendicitis, (6) ICD-10 Condition: K37||Unspecified appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3ml of 0.5% Bupivacaine   0.5% hyperbaric bupivacaine 3.0 ml (12.5 mg) in a 5.0 ml syringe.  
Comparator Agent  3ml of 0.5% hyperbaric Bupivacaine with 0.5 ml (25 micrograms) of Fentanyl  0.5% hyperbaric Bupivacaine 3.0 ml (12.5mg) by 5.0 ml syringe followed by 0.5 ml (25 micrograms) of Fentanyl in a 1.0 ml syringe 
Comparator Agent  3ml of 0.5% hyperbaric Bupivacaine with 0.5 ml of normal saline  0.5% hyperbaric Bupivacaine 3.0 ml (12.5 mg) in a 5.0 ml syringe followed by 0.5 ml of normal saline in 1.0 ml syringe.  
Intervention  Subarachnoid Block  Subarachnoid Block will be given in L4 - L5 vertebral space with 25G spinal needle in lateral position. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for elective below umbilical surgeries under subarachnoid block.
2.Patients of either sex between 18-55years of age
3.Patient under ASA CLASS I/ II
4.Patients willing to give written and informed consent
 
 
ExclusionCriteria 
Details  1.Patient under ASA CLASS III, IV & V

2.HIV, HbsAg, HCV positive patients

3.Non-consenting patients.
4.Patients with Local site sepsis or any contraindication for subarachnoid block.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the onset and duration of sensory and motor blockade, highest level of
anesthesia and total duration of analgesia with bupivacaine alone or when either
Fentanyl or saline is injected subsequent to Bupivacaine for spinal anesthesia.
 		 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), arterial oxygen saturation on pulse oximetry (SpO2).
2.To assess the requirement of postoperative rescue analgesia.
3.To study the postoperative side effects viz Nausea, vomiting, Itching, Urinary retention, respiratory depression etc.
 		 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   09/03/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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)?  

Response - NO
Brief Summary
Modification(s)  		 After getting clearance from Institute Ethics Committee and written informed consent of eligible patients, 90 patients aged 18-60 years, American Society of Anesthesiology grade I and II scheduled for elective lower abdominal surgeries will be enrolled in this study. On arrival patients will be connected to monitor and thereafter will be randomly allocated to three groups of 30 patients each. the investigator will remain blinded to the group allocation and the drug used. Patients in group A will receive 0.5% hyperbaric Bupivacaine 3.0 ml (12.5mg) in 5.0 ml syringe. Group B will receive 0.5% hyperbaric Bupivacaine 3.0 ml in a 5.0 ml syringe followed by 0.5 ml of normal saline in 1.0 ml syringe. Group C will receive 0.5% of hyperbaric Bupivacaine 3.0 ml in 5.0 ml syringe followed by 0.5 ml (25 microgram) of Fentanyl in 1.0 ml syringe.
Subarachnoid block will be administered at L 3-4 intervertebral space in lateral decubitus position.
onset of sensory block will be assessed by sterile pin prick every 2min till 20 mins and then after every 10 mins till highest level will be achieved. Sensory onset will be defined as the loss of sensation at T10 level and motor onset when modified Bromage score turns 3. Time of regression of moto blockade will be assessed by modified Bromage score becomes 0.
Vital parameters of the patients will be assessed periodically till completion of procedure. Time till the requirement of first rescue analgesia will be recorded. Entire data would be entered into Microsoft office software, appropriate statistical test will be applied and results will be calculated.
 
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