FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065735 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the characteristics of premixed hyperbaric ropivacaine and fentanyl versus hyperbaric ropivacaine and fentanyl given separately during spinal anesthesia (anaesthesia technique in which drug is injected in lower back of the patient). 
Scientific Title of Study   Comparison of subarachnoid block characteristics using pre-mixing versus sequential injection of fentanyl and hyperbaric ropivacaine (0.75%) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Gehlaut 
Designation  Professor 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  8950285434  
Fax    
Email  preeti.gehlaut@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Punit Kumar 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  7834994170  
Fax    
Email  parulgrover89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Punit Kumar 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak Haryana


HARYANA
124001
India 
Phone  7834994170  
Fax    
Email  parulgrover89@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS, Rohtak Haryana 
Address  Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak Haryana 
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 Punit Kumar  Pt B D Sharma PGIMS, Rohtak  Department of Anesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak Haryana
Rohtak
HARYANA 		 7834994170

parulgrover89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bio Medical Research Ethics Committee , Pt B D Sharma PGIMS/ UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, (2) ICD-10 Condition: M25||Other joint disorder, not elsewhere classified, (3) ICD-10 Condition: M20-M25||Other joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pre-mixing of injection fentanyl and hyperbaric ropivacaine 0.75%.  Sandardised anaesthesia protocol will be followed. In sitting position, under all aseptic precautions, 25- gauge Quinckes spinal needle will be inserted intrathecally at L3-L4 or L4-L5 intervertebral space. after observation of clear, free flow of cerebrospinal fluid through the needle the study drugs will be given as pre mixed solution via a single syringe. Sensory block will be assessed at 1 minute interval by using alcohol swab in the mid-clavicular line, bilaterally, till T10 level is achieved. Time will be noted and surgery will be started. However, sensory level will be checked every 1 minute thereafter, till the time the sensory level is noted to be the same for 2 consecutive intervals. This level will be taken as the maximum sensory level achieved and last but one reading, in minutes, will be taken as time to achieve the maximum level. 
Comparator Agent  Sequential injection fentanyl and hyperbaric ropivacaine 0.75%.  Sandardised anaesthesia protocol will be followed. In sitting position, under all aseptic precautions, 25- gauge Quinckes spinal needle will be inserted intrathecally at L3-L4 or L4-L5 intervertebral space. After observation of free flow of clear cerebrospinal fluid through the needle the study drugs will be given in a sequential manner via two separate syringes, where fentanyl will be injected first followed by hyperbaric ropivacaine. Sensory block will be assessed at 1 minute interval by using alcohol swab in the mid-clavicular line, bilaterally, till T10 level is achieved. Time will be noted and surgery will be started. However, sensory level will be checked every 1 minute thereafter, till the time the sensory level is noted to be the same for 2 consecutive intervals. This level will be taken as the maximum sensory level achieved and last but one reading, in minutes, will be taken as time to achieve the maximum level. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The study will include 80 patients of either sex of age 18-65 years, belonging to American Society of Anesthesiologists (ASA) physical status of I-II scheduled for lower Limb surgery sub-arachnoid block. 
 
ExclusionCriteria 
Details  Patient refusal to participate
Contraindication to spinal anaesthesia
Known to allergy to local anaesthesia
Pregnancy 
 
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 compare the total duration of sensory block in both the groups.  Sensory block will be assessed at 1 minute interval by using alcohol swab in the mid-clavicular line, bilaterally, till T10 level is achieved. Time will be noted and surgery will be started. However, sensory level will be checked every 1 minute thereafter, till the time the sensory level is noted to be the same for 2 consecutive intervals. This level will be taken as the maximum sensory level achieved and last but one reading, in minutes, will be taken as time to achieve the maximum level. 
 
Secondary Outcome  
Outcome  TimePoints 
Onset, highest level attained, motor block, hemodynamics parameters.   Motor blockade will be assessed every 5 minutes and the maximum motor level achieved at 20 minutes from the intrathecal injections of drugs , as per modified bromage scale.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 present prospective study will be conducted in the department of anaesthesia and critical care, PGIMS Rohtak. Written informed consent will be taken from patients included . then assessment and comparison of subarachnoid block characteristics using pre-mixing versus sequential injection of fentanyl and hyperbaric ropivacaine 0.75%.Data will be compiled and analysed with appropriate statistical tests. 
Close