FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037039 [Registered on: 01/10/2021] Trial Registered Prospectively
Last Modified On: 30/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of consecutive versus premixed administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section 
Scientific Title of Study   A comparative study of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Seema Jindal 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Guru Gobind Singh Medical College And Hospital, Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  9646050485  
Fax    
Email  jindalseema77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Jindal 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Guru Gobind Singh Medical College And Hospital, Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  9646050485  
Fax    
Email  jindalseema77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shveta Goyal 
Designation  Junior Resident MD Anaesthesiology 
Affiliation  Guru Gobind Singh Medical College And Hospital, Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  7986192347  
Fax    
Email  shvetagoyal99@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical College And Hospital, Faridkot 
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 Seema Jindal  Guru Gobind Singh Medical College And Hospital, Faridkot  Department of Anesthesiology
Faridkot
PUNJAB 
9646050485

jindalseema77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of GGS Medical College And Hospital, Faridkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80-O82||Encounter for delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Consecutive versus premixed administration of hyperbaric bupivacaine and fentanyl  In one technique, patients will receive hyperbaric bupivacaine and fentanyl in premixed form in single syringe in neuraxial anaesthesia. In other techniques, patients will receive hyperbaric bupivacaine and fentanyl consecutively in separate syringes in neuraxial anaesthesia for caesarean section. 
Intervention  Hyperbaric bupivacaine and fentanyl  Time of onset of sensory block will be assesed after administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  •Patients belonging to American Society of Anesthesiologist Grade I and II
•Parturients aged 18-35 years undergoing caesarean section
 
 
ExclusionCriteria 
Details  •Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation
•BMI greater than 35 or less than 22 Kg/m2
•Height less than 150 cm and greater than 170 cm
•Gestational age less than 36 weeks
•Major systemic diseases (cardiac, renal, liver)
•Having allergy to drugs used in the study
•Patients having neuropathies
•Having contraindications for spinal anaesthesia

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
•To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
•To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
 
Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min. 
 
Secondary Outcome  
Outcome  TimePoints 
•Time of onset of motor block
•Time of regression of sensory block.
•Time of regression of motor block.


 
Time of onset of motor block will be assessed every 5 min. for 20 min.
Time of regression of sensory and motor block will be assessed.
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   11/10/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Introduction: Spinal anaesthesia is the preferred technique for caesarean section being easy to perform, cost effective, having higher efficiency, causing lesser neonatal depression and decreased risk of aspiration of gastric contents. Hyperbaric bupivacaine is commonly used local anaesthetic for spinal anaesthesia in caesarean section .Local anaesthetics in neuraxial anaesthesia block motor and sensory system. They also block sympathetic nervous system which causes unwanted physiological alterations. Certain adjuvants like fentanyl are used to minimize the side effects of local anaesthetics by bringing down their volume. Addition of fentanyl to hyperbaric bupivacaine may alter the density of the mixture and affect the spread of hyperbaric bupivacaine. If both drugs are injected separately in different syringes, it may minimize the effect of changes in densities and pH of both drugs.
Aims and Objectives:
  • To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
  • To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
  • To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
  • To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
Materials and Methods:Study will be conducted in the Department of Anaesthesiology at Guru Gobind Singh Medical College and Hospital, Faridkot. Inclusion criteria: (1) Patients belonging to American Society of Anaesthesiologist Grade I and II. (2) Parturients aged 18-35 years undergoing caesarean section. Exclusion criteria: (1) Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation. (2) BMI greater than 35 or less than 22 Kg/m2. (3) Height less than 150 cm. and greater than 170 cm. (4) Gestational age less than 36 weeks. (5) Major systemic diseases (cardiac, renal, liver). (6) Having allergy to drugs used in the study. (7) Patients having neuropathies. (8) Having contraindications for spinal anaesthesia.
Methodology:A total of 120 patients divided into 3 groups (40 each) i.e. Group A: Patients receiving 2.0 ml of 0.5% hyperbaric bupivacaine followed by 25 mcg of fentanyl through separate 3 ml syringes, Group B: Patients receiving 25 mcg of fentanyl followed by 2.0 ml of 0.5% hyperbaric bupivacaine through separate 3 ml syringes, Group C: Patients receiving 2.0 ml of 0.5 % hyperbaric bupivacaine + 25 mcg of fentanyl premixed in a 3 ml syringe.
Parameters assessed:Onset of sensory block in 3 groups, Onset of motor block in 3 groups, Time of regression of sensory block, Time of regression of motor block, Vital parameters of patient like pulse rate, blood pressure, SPO2, frequency of hypotension, need for vasopressors, Requirement of rescue analgesia, Neonatal outcome in the form of Apgar score, Patient satisfaction score.
 
Close