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CTRI Number  CTRI/2024/07/069884 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative analysis of intrathecal hyperbaric ropivacaine o.75% with fentanyl versus hyperbaric bupivacaine 0.5% with fentanyl in elective lower abdominal surgery  
Scientific Title of Study   Comparision of efficacy of intrathecal hyperbaric(0.75%) Ropivacaine with fentanyl and hyperbaric (0.5%) Bppivacaine with fentanyl in elective lower abdominal surgeries-A prospective randomised double blind clinical study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhuriya Mittal Himabhai 
Designation  Resident Doctor  
Affiliation  Government Medical College Vadodara  
Address  Department of Anesthesiology ,SSG Hospital , Government Medical College Vadodara

Vadodara
GUJARAT
390001
India 
Phone  7990283548  
Fax    
Email  mittalbhuriya94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kashmira Pander 
Designation  Assistant professor  
Affiliation  Government Medical College Vadodara  
Address  Department of Anesthesiology,SSG Hospital, Government Medical College,Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9099045151  
Fax    
Email  dr.kashmira13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhuriya Mittal Himabhai  
Designation  Resident Doctor  
Affiliation  Government Medical College Vadodara  
Address  Department of Anesthesiology SSG hospital, Government Medical College vadodara

Vadodara
GUJARAT
390001
India 
Phone  7990283548  
Fax    
Email  mittalbhuriya94@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology,2nd floor OT block,SSG Hospital vadodara State-gujarat District -vadodara Pin-39001 
 
Primary Sponsor  
Name  Government Medical College Vadodara  
Address  Department of Anesthesiology,SsG Hospital, Government Medical College Vadodara  
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 Mittal Himabhai Bhuriya  SSG Hospital ,vadodara  2nd and 3rd floor Surgical Operation Theatre ,New surgical block, SSG Hospital vadodara
Vadodara
GUJARAT 
7990283548

mittalbhuriya94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comitte for biomedical and health research (IECBHR) medical college SSG Hospital vadodara   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, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: 8||Other Procedures, (4) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric bupivacaine (0.5%)3 ml with fentanyl 0.5 ml given for subarachanoid block   Hyperbaric bupivacaine (15 mg)3 ml and Fentanyl (25 mcg)0.5 ml Total 3.5 ml volume of drug will be given intrathecally in L3-L4 intervertebral space to another group and primary and secondary outcome will be assesed every 15 sec for 2 min and then every minute for 10 min and then every 30 minute during surgery. 
Intervention  Hyperbaric Ropivacaine (0.75%)3ml with fentanyl0.5 ml given for subarachanoid block  Hyperbaric Ropivacaine 22.5 mg(3 ml) and fentanyl 25 mcg(0.5 ml) Total 3.5 ml volume of drug will be given intrathecally in L3-L4 intervertebral space to one group and primary and secondary outcome will be assessed every 15 sec for 2 mins and then every min for 1o min and then every 30 min during surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA1/2
Elective lower abdominal surgery (Hernioplasty,Herniorraphy,hydrocele repair,Appendecectomy,perineal surgery)
Duration of surgery 1.5 to 2 hours 
 
ExclusionCriteria 
Details  Patient refusal
Patient with uncontrolled systemic disease
, psychiatric illness,local site infection ,allergic to local anesthetic and adjuvant,spine deformity,previous spine surgery ,height less than 140 cm,BMI more than 30 kg/m2, pregnant women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset of sensory block at L1 dermatome level ,time to achive maximum sensory level,Time for two segment regression,Total duration of sensory block
Onset of motor blockade,Time to achieve complete motor blockade, maximum motor blockade,Total duration of motor blockade 
Every 15 sec for 2 minutes and then every minute for 10 minute after completion of intrathecal injection and then every 30 minute during surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Any changes in hemodynamic parameters loke pulse rate,blood pressure,spo2 perioperatively
Time to first micturation,
Time for mobilisation  
1 min 3 min 5 min 10 min 20 min 30 min 60 min 90 min 120 min 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   Phase 4 
Date of First Enrollment (India)   15/07/2024 
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="6"
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   This study is randomised controlled trial comparing efficacy of intrathecal hyperbaric ropivacaine (0.75%)with fentanyl and hyperbaric bupivacaine (0.5%) with fentanyl for sensory and motor blockade charactrristics in elective lower abdominal surgery for subarachanoid block

Grouping of Patients-
The patients will be randomly allocated into two groups by using computer Generated random numbers which is contained in a sealed envelope
Group RF Inj. Hyperbaric Ropivacaine 0.75% 3 ml + fentanyl 25 mcg(0.5ml)
Group BF  Inj. Hyperbaric Bupivacaine 0.5% 3 ml+ fentanyl 25 mcg(0.5 ml)

After preoperative evaluation and 8 hours of fasting informed written consent will be taken from the patient
Then patient will be taken inside operation Theatre multipara monitor will be attached and all baseline parameters will be recorded 
Good iv access will be taken and premedication and adequate preloading will be done 30 mins prior to induction

DRUG PREPARATION

Group RF – Inj.Hyperbaric 0.75% Ropivacaine 3 ml + fentanyl 0.5ml (25 mcg) Total drug volume=3.5 cc
Injection Ropivacaine heavy ampoule available in 0.75% 4 ml, each ml contains 7.5 mg drug, out of which 3 ml drug will be taken that is 22.5mg 
Injection fentanyl ampoule available in 2 ml each ml contains 50 mcg drug out of which 0.5 ml drug will be taken that is 25 mcg
Group BF - Inj. Hyperbaric 0.5% Bupivacaine 3 ml+ Fentanyl 0.5 ml (25mcg)Total drug volume=3.5 cc
Injection Bupivacaine heavy ampoule available in 0.5% 4 ml, each ml contains 5 mg drug out of which 3 ml drug taken that is 15 mg
Injection fentanyl ampoule available in 2 ml, each ml contains 50 mcg drug out of which 0.5 ml drug will be taken that is 25 mcg
Total drug volume=3.5 cc

The patient will be kept in lateral position and under all aseptic and antiseptic precautions  using a 23 G Quincke spinal needle s will be inserted in  L3 -L4 intervertebral space (midline approach). After confirmation of free and clear CSF flow with the bevel of the needle pointing cephalic drug will be injected intrathecally 0.2ml/seconds according to Group.  
Patient is immediately put in supine position without raising extremities and keeping operation table horizontal position ,monitoring of parameters will be started immediately.
Surgery will be allowed once the sensory blockade(T10) and motor blockade (Bromage 3) are achieved.

Following parameters will be recorded in both of groups.
Sensory blockade characteristics -
1)Onset of sensory Block at L1 level(min)
2)Time to achieve highest sensory level(min)
3)Time of two segment regression from highest level of block(min)
4) Duration of sensory block(min)

Motor blockade charactrristics -
1) Onset of motor blockade(min)
2) Maximum motor blockade achieved(min)
3) Time to attain maximum motor block(min)
4) Duration of motor block(min)

Intra operative monitoring of pulse rate,blood pressure and spo2 will be monitored continuousily at regular intervals(baseline,1st,3rd,5th minute,10 minutes,every 10 minutes till 30 minutes,then half hourly till end of surgery.
Time to first micturation (min)
Time for mobilisation (min)



 
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