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CTRI Number  CTRI/2023/06/053712 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 07/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF TWO DRUGS FOR SPINAL ANESTHESIA IN ABDOMINAL SURGERIES  
Scientific Title of Study   Segmental Spinal Anaesthesia Comparing Isobaric Levobupivacaine Versus Isobaric Ropivacaine For Abdominal Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpa Patel 
Designation  Professor 
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIOLOGY, PRAMUKHSWAMI MEDICAL COLLEGE, SHREE KRISHNA HOSPITAL, KARAMSAD, ANAND, GUJARAT

Anand
GUJARAT
388325
India 
Phone    
Fax    
Email  alpamp@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alpa Patel 
Designation  Professor 
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIOLOGY, PRAMUKHSWAMI MEDICAL COLLEGE, SHREE KRISHNA HOSPITAL, KARAMSAD, ANAND, GUJARAT


GUJARAT
388325
India 
Phone    
Fax    
Email  alpamp@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Prapti Patel 
Designation  1st year resident 
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIOLOGY, PRAMUKHSWAMI MEDICAL COLLEGE, SHREE KRISHNA HOSPITAL, KARAMSAD, ANAND, GUJARAT

Anand
GUJARAT
388325
India 
Phone    
Fax    
Email  praptipatel2691995@gmail.com  
 
Source of Monetary or Material Support  
SHREE KRISHNA HOSPITAL, KARAMSAD 
 
Primary Sponsor  
Name  SHREE KRISHNA HOSPITAL 
Address  SHREE KRISHNA HOSPITAL KARAMSAD, ANAND, GUJARAT 
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 
DrAlpa Patel  PRAMUKH SWAMI MEDICAL COLLEGE, shree Krishna medical hospital  Department of Anesthesiology, Surgical Operation Theater Complex, Anand GUJARAT
Anand
GUJARAT 
9825084282

alpamp@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ISOBARIC LEVOBUPIVACAINE WITH FENTANYL  assess onset and duration of sensory block, motor block and duration of analgesia by 10 mg of isobaric levobupivacaine with 25mcg of fentanyl given via spinal anesthesia 
Comparator Agent  ISOBARIC LEVOBUPIVACAINE WITH FENTANYL versus ISOBARIC ROPIVACAINE WITH FENTANYL  Compare onset and duration of sensory block, motor block and duration of analgesia by 10 mg of isobaric levobupivacaine with 25mcg of fentanyl versus 10mg of isobaric ropivacaine with 25mcg of fentanyl given via spinal anesthesia  
Intervention  ISOBARIC ROPIVACAINE WITH FENTNYL  assess onset and duration of sensory block, motor block and duration of analgesia by 10 mg of isobaric ropivaciane with 25mcg of fentanyl given via spinal anesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Patients of ASA I to ASA III (American society of anaesthesia) physical status
2) Age >18yrs of either sex
3) Patients undergoing major and minor abdominal surgeries 
 
ExclusionCriteria 
Details  1) Patients refusal for segmental spinal anaesthesia
2) Infection at site of spinal needle insertion
3) Patients having allergy to local anesthetic drug
4) Coagulopathy or bleeding disorder
5) Increased intracranial pressure
6) Any other relative contraindications of segmental spinal anesthesia 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of isobaric levobupivacaine with isobaric ropivacaine in abdominal
surgeries under segmental spinal anaesthesia 
Sensory, motor and vitals assessment every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till
completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
-To assess onset and duration of sensory block, motor block and duration of analgesia by
isobaric solutions of levobupivacaine and ropivacaine with addition of fentanyl
-To assess the the effects of isobaric solutions of levobupivacaine and ropivacaine
in segmental spinal anaesthesia in view of hemodynamic stability 
Sensory, motor and vitals assessment every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till
completion of surgery 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   30/06/2023 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After obtaining ethical committee approval and obtaining written and informed consent, patients
of ASA I to III (American society of anesthesia) physical status who are undergoing elective major and minor
abdominal surgeries under segmental spinal anaesthesia will be recruited to participate in the study. It is a
double blind randomized control trial study. Total 64 patients, 32 in each group will be randomized into Group
L- to receive 2 ml of isobaric levobupivacaine (0.5%) with 25 mcg of fentanyl and Group R- to receive 2 ml of
isobaric ropivacaine (0.5%) with 25 mcg of fentanyl using winpepi software.
 Pre anesthetic check up will be carried out in all patients with detailed history, general and systemic
examination and investigations. Informed written consent will be taken from patients after explaining all
benefits and risks of the procedure. After checking the adequate hours of nil by mouth, arrival to the pre￾operative room temperature, heart rate, respiratory rate, blood pressure and spo2 will be recorded in all
patients, an intravenous line will be secured and patients will be preloaded with iv fluids half an hour before
anaesthesia according to patient profile. All patients in both group will be given i.v ranitidine and ondansetron.
All patients in both group will be given inj.Midazolam 0.02mg/kg i.v prior to surgery.
 In both Group-L and Group-R, the patients will be placed in sitting position, under all aseptic
precautions skin and subcutaneous tissue will be infiltered with 2ml of 2% lignocaine. 23 G/25 G Quincke’s
spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of
cerebrospinal fluid, spinal anaesthesia will be given with 2 ml of isobaric levobupivacaine (0.5%) with 25 mcg of
fentanyl in Group-L and 2 ml of isobaric ropivacaine (0.5%) with 25 mcg of fentanyl in Group-R in T7-T8/T8-T9
space through a midline/paramedian approach. Our goal is to achieve the blockade from T4 to L2 dermatome
level. After injection, patients will be placed in supine position immediately. Sensory effect will be assessed by
pin prick method every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till
completion of surgery. Motor effect will be assessed by Modified Bromage scale
Bromage Grading Effect
Grade 0 no motor block & able to flex hips,knees and ankles
Grade 1 just able to flex knees but unable to flex legs
Grade 2 able to move ankles but unable to flex knees
Grade 3 unable to flex ankles, knees or hips, complete motor block
Modiefied Bromage Scale will be assessed every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes
and every 15 minutes till completion of surgery.
Using a preformed structured proforma the following parameters will be recorded: onset of sensory blockade,
onset of motor blockade (Bromage scale 1), maximum dermatomal level of sensory blockade achieved and the
time to achieve it, two segment sensory regression time, maximum grade of motor blockade attained and the 
time to achieve it, total duration of analgesia (time to regression to L1) and the duration of motor blockade
(regression to bromage 0). Other parameters such as total duration of surgery, total intraoperative fluid given,
hemodynamic monitoring till the full recovery of sensory and motor blockade will be noted. Patients will be
also monitored for any adverse effects like bradycardia, hypotension, nausea, vomiting, headache, shoulder
pain, pruritus, urinary retention and any hypersensitivity reactions to drug.[4] Hypotension (SBP<90mmhg or
30%fall in SBP from baseline value) will be treated with rapid i.v fluid boluses and if needed
sympathomimetic drugs will be given. Bradycardia (HR<60bpm) will be treated with inj. Atropin 0.6mg iv. In
case of failure of analgesia and anaesthesia, we have back up of general anaesthesia in all cases.
 In PACU, patients will be monitored post operatively for 1 hour in view of temperature, pulse,
respiratory rate, blood pressure, spo2. In the post operative period, iv fluid and analgesia will be given
according to standard protocol of an institute.
After completion of surgery, time will be noted till regression of Sensory effect at L2 level is achieved. This will
indicate the end of analgesic effect of drug given.
 Surgeon will be asked about their satisfaction for depth of anaesthesia achieved during surgery.
Based on their experience, they will be asked to rate their level of satisfaction using the Likert 5 point
satisfaction scale￾Rating Satisfaction
5 Totally satisfied
4 Satisfied
3 Not satisfied
2 Unsatisfied
1 Totally unsatisfied
 
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