| 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
|
|
|
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
|
|
|
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 |
|
|
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. |