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CTRI Number  CTRI/2025/11/097264 [Registered on: 12/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To compare the incidence of nausea and vomiting after cesarean section when Buprenorphine is administered in different routes 
Scientific Title of Study   To compare the effect of Intrathecal Buprenorphine Versus Buprenorphine in the Transversus Abdominis Plane(TAP) Block on Post Operative Nausea and Vomiting among subjects under going elective Cesarean Section:A Randomised Comparitive 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  DR Kamalieshree M 
Designation  Post Graduate Student 
Affiliation  Bangalore Medical College and RI  
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  8608021339  
Fax    
Email  kamaliteja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Bhaskara B 
Designation  Associate professor 
Affiliation  Bangalore Medical College and RI 
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9902016020  
Fax    
Email  drbhaskar.md@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Bhaskara B 
Designation  Associate professor 
Affiliation  Bangalore Medical College and RI 
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9902016020  
Fax    
Email  drbhaskar.md@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, KR road, Fort, Bengaluru. Bangalore KARNATAKA-560002 India  
 
Primary Sponsor  
Name  Dr Kamalieshree M 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru. Karnataka -560002 India  
Type of Sponsor  Other [Self ] 
 
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 Kamalieshree M   Bangalore Medical College and Research Institute   3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru
Bangalore
KARNATAKA 
8608021339

kamaliteja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Bangalore Medical College & Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buprenorphine 60mcg in the Transversus Abdominal Plane block   To assess the incidence of post operative nausea and vomiting upon addition of Buprenorphine 60mcg in Transversus Abdominis Plane block in parturients undergoing cesarean section under spinal anaesthesia  
Intervention  Intrathecal buprenorphine 60mcg  To assess the incidence of post operative nausea and vomiting upon addition of Buprenorphine 60mcg intrathecally in parturients undergoing elective cesarean section under spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Parturient willing to give informed consent
Age between 18-45yrs
Parturients posted for elective cesarean section
Parturients with ASA grade II
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of incidence of post operative nausea and vomiting using likert scale in the first 24hours.
Assessment of severity of nausea using visual analogue scale (VAS) in first 24 hours
Assessment of post operative pain using 11 point numerical scale in first 24 hours

 
Immediate post operative to 24 hours


 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of anesthesia (from the start of spinal anaesthesia to end of surgery)
Time for 1st rescue analgesia
Duration of Recovery (from the end of anaesthesia to post operative period)
Heart rate (HR), ECG, Non invasive blood pressure(SBP/DBP), Oxygen saturation(SpO2), respiratory rate(RR).
The occurrence of postoperative complications such as bradycardia, hypotension, post dural puncture headache, post operative nausea and vomitting

 
Immediate post operative to 24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   22/11/2025 
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="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

After obtaining approval and clearance from the institutional ethics committee, the parturients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. (Annexure – 1). Parturients belonging to ASA Grade II (Annexure -2) will be chosen
Parturients will be randomly assigned to two equal groups as Group 1 (spinal anaesthesia with intrathecal bupivacaine) and Group 2 (spinal anaesthesia with TAP block). A computergenerated random numbers will be used to allocate participation for each group using www.randomization.com
The anaesthetic procedure will be standardized.The explanation regarding the procedure and post operative follow up will be done during the pre operative checkup.Once the parturient arrives to the recovery two 18G cannula will be secured.500ml ringer lactate solution or 0.9% normal saline  is infused prior anaesthesia.Once Parturient gets shifted to OT all the standard monitors will be attached, baseline vitals will be noted.Then the parturients will be positioned into  lateral position, under sterile aseptic precautions dural puncture will be done in L3-L4 intervertebral space using 25G Quincke’s babcock spinal needle and after ensuring the flow of csf Group 1 parturients will receive 1.8ml of 0.5% Hyperbaric Bupivacaine plus 0.2ml of Buprenorphine intrathecally and group 2 parturients will receive 1.8ml of 0.5% Hyperbaric Bupivacaine with 0.2ml of normal saline intrathecally. Hemodynamic parameters such as BP, HR spo2 will be monitored for every three minutes for the first 15minutes and every 5 minutes once the baby is extracted. Once the skin closure is done group 2 will receive ultrasound guided transversus abdominis plane block on each side with Inj burenorphine 60mcg.Parturients will be monitored for 10 minutes in the post operative anaesthesia care unit after cesarean section and will be shifted to the wards later.
The parturients will be monitored post operatively for the incidence of post operative nausea and vomiting (PONV) in the first 24 hours. The observer will be blinded regarding the parturients. The primary outcome parameter will be the PONV incidence within 24hrs post operatively. The severity of post operative nausea and vomiting during this period will be assessed using likert scale (Annexure 3) from 0 to 10. PONV will be defined as vomiting,marked nausea [numerical rating scale (NRS>4)], and/or need for rescue medication.Parturients will be assessed for PONV at 0.2.4,12, and 24 hours using the likert scale.
·        Nausea and it’s severity, vomiting attacks,pain and it’s severity,need for additional analgesics,and administration of antiemetic rescue medications, drowsiness of the parturients(Annexure 4)will be evaluated as secondary parameters.The degree of nausea was evaluated using the visual analogue scale (VAS)(Annexure 5)with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting.When the PONV score was greater than 4 or when vomiting occurs 11 point numerical rating scale for pain (0= no pain and 10= worst possible pain )(Annexure 6)will be explained. In addition to this the rescue antiemetic requirement, number of additional antiemetic applications, rescue analgesic requirement and number of additional analgesic applications will also be Parturients will be monitored for 24 hours post operatively.
 
 
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