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CTRI Number  CTRI/2022/08/044572 [Registered on: 02/08/2022] Trial Registered Prospectively
Last Modified On: 01/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs buprenorphine and dexmedetomedine given intrathecally in pregnant patients undergoing caesarean section. 
Scientific Title of Study   Comparison between intrathecal buprenorphine versus dexmedetomidine with hyperbaric Ropivacaine 0.75% in patients undergoing caesarean section.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE, GULBARGA 
Address  ESIC MEDICAL COLLEGE, SEDAM ROAD B-414, Bharat Pride Park, Humnabad Road, Gulbarga- 585105, Karnataka , India.

Gulbarga
KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472-265545  
Email  priyankakanni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE, GULBARGA 
Address  ESIC MEDICAL COLLEGE, SEDAM ROAD B-414, Bharat Pride Park, Humnabad Road, Gulbarga- 585105, Karnataka , India.


KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472-265545  
Email  priyankakanni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC MEDICAL COLLEGE, GULBARGA 
Address  ESIC MEDICAL COLLEGE, SEDAM ROAD B-414, Bharat Pride Park, Humnabad Road, Gulbarga- 585105, Karnataka , India.


KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472-265545  
Email  priyankakanni@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College, Gulbarga. 
 
Primary Sponsor  
Name  ESIC Medical College Gulbarga 
Address  ESIC Medical College, Sedam Road, Gulbarga-585105 
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 Priyanka Y Kanni  ESIC Medical College, Gulbarga.  Department of Anaesthesiology, 3rd floor, ESIC hospital building,Gulbarga-585105
Gulbarga
KARNATAKA 		 9908290999
08472-265545
priyankakanni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, ESIC Medical College, Gulbarga  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection Buprenorphine  60mcg given intrathecally at the time of spinal anaesthesia  
Intervention  Injection Dexmeditomedine  10mcg given intrathecally at the time of spinal anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients with

1.Singleton pregnancy, scheduled for elective caesarean section under spinal anaesthesia
2.More than 36 weeks of gestation age
3.18-40 years of age
4.Height between 140cm and 180cm
5.BMI less than 32kg/m2,
6.Nil per oral for more than 6 hours





 
 
ExclusionCriteria 
Details  1.Multiple pregnancy
2.Morbid Obesity (BMI >40)
3.Height <140 cms & >170cms
4.Patients with spinal deformities and those who have undergone previous spine surgeries.
5.Pregnancy related hypertensive disease, preeclampsia, eclampsia.
6.Cardiovascular disease
7.Gestational diabetes requiring insulin.
8.Emergency caesarean sections for maternal or foetal distress.
9.Contraindication to spinal anesthesia.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To study the onset time and duration of sensory and motor block.
2. To know the time of first analgesic used.
3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.
 		 1. To study the onset time and duration of sensory and motor block in pregnant patients who receive the study drug.
2. To know the time of first analgesic used.
3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study hemodynamic parameters.
2. Side effects like hypotension, bradycardia, shivering, vomiting.
 		 1. To study hemodynamic parameters till the end of surgery.
2. Side effects like hypotension, bradycardia, shivering, vomiting during the surgery and postoperative period.
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   04/08/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankakanni@gmail.com].

  6. For how long will this data be available start date provided 30-06-2023 and end date provided 30-06-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Subarachanoid block is the anaesthetic technique of choice in pregnant patients with low risk pregnancy undergoing caesarean section since it provides easy and rapid induction with effective sensory and motor bloackade with no significant effects on fetus.Intrathecal Ropivacaine has gained popularity as an alternative to intrathecal Bupivacaine hydrochloride because of its reduced risk of carditoxicity, neurotoxicity and good haemodynamic stability. Ropivacaine has its own limitation of short duration of anaesthesia, which can be overcome by adding adjuvants to local anaesthetics. The supplementation of local anaesthetics with adjuants is done to reduce the dose of local anaesthetics, minimise the side effects and prolong the duration of intra and post-operative analgesia with good haemodynamic stability. From time to time, various methods including addition of adjuants to local anaesthetics have been tried but with a varying success. Many studies using adjuants like opoids and alpha-2 agonist to bupivacaine are available in literature whereas few studies have been done using these adjuants with ropivacaine. On searching the literature , we did not come across any study comparing the effects of buprenorphine and dexmedetomedine with intrathecal hyperbaric Ropivacaine 0.75% in pregnant patients and better adjuant among these two agents still needs to be explored. Hence the study is conducted to assess the effectiveness of buprenorphine versus dexmedetomedine when used as adjuants to intrathecal hyperbaric ropivacaine 0.75% for prolongation of inta and post-operative analgesia in pregnant patients.  
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