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CTRI Number  CTRI/2025/08/093582 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two different doses of clonidine when added to ropivacaine in an ultrasound-guided abdominal nerve block (Transversus Abdominis Plane Block) for relieving pain after caesarean delivery 
Scientific Title of Study   Comparison of two different doses of clonidine as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block for post caesarean analgesia–A prospective double blinded randomized controlled 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  Mirthan krish B 
Designation  Post graduate 1st year 
Affiliation  Sri Venkateshwaraa medical college hospital and research center 
Address  Department of Anesthesiology SVMCH RC 2nd floor OT complex NO 13-A Pondy Villupuram Main road Ariyur Puducherry Pondicherry PONDICHERRY 605102 India

Pondicherry
PONDICHERRY
605107
India 
Phone  9488552340  
Fax    
Email  mirthankrish08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRJayashri devi 
Designation  Professor 
Affiliation  Sri Venkateshwaraa medical college hospital and research center 
Address  Department of Anesthesiology SVMCH RC 2nd floor OT complex NO 13-A Pondy Villupuram Main road Ariyur Puducherry Pondicherry PONDICHERRY 605102 India

Pondicherry
PONDICHERRY
605107
India 
Phone  8754689690  
Fax    
Email  dr.jayashridevi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mirthan krish B 
Designation  Post graduate 1st year 
Affiliation  Sri Venkateshwaraa medical college hospital and research center 
Address  Department of Anesthesiology SVMCH RC 2nd floor OT complex NO 13-A Pondy Villupuram Main road Ariyur Puducherry Pondicherry PONDICHERRY 605102 India

Pondicherry
PONDICHERRY
605107
India 
Phone  9488552340  
Fax    
Email  mirthankrish08@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology SVMCH RC 2nd floor OT complex NO 13-A Pondy Villupuram Main road Ariyur Puducherry Pondicherry PONDICHERRY 605102 India  
 
Primary Sponsor  
Name  Mirthan Krish B 
Address  Department of Anesthesiology SVMCH RC 2nd floor OT complex NO 13-A Pondy Villupuram Main road Ariyur Puducherry Pondicherry PONDICHERRY 605102 India  
Type of Sponsor  Other [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 Mirthan Krish B  Sri Venkateshwaraa medical college,hospital and research centre  Department ofAnaesthesiology, OT complex, 2nd floor,no 1, Pondy Villupuram main road, Ariyur Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY 		 09488552340

mirthankrish08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies) (Reg No: EC/NEW/INST/2024/PY/0418, NECRBHR, DHR, GOI)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of two different doses of clonidine as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block for post caesarean analgesia–A prospective double blinded randomized controlled study  Subject who receive 1.0 mcg/kg clonidine with 0.2%ropivicaine 20ml for Posterior TAP block on each side for 24 hours. [total volume 40ml] [normal dose of clonidine-1mcg/kg] 
Intervention  Comparison of two different doses of clonidine as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block for post caesarean analgesia–A prospective double blinded randomized controlled study  Subject who receive 0.5mcg/kg clonidine with 0.2%ropivicaine 20ml for Posterior TAP block on each side for 24 hours. [total volume 40ml] [normal dose of clonidine-1mcg/kg] 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  44.00 Year(s)
Gender  Female 
Details  Parturients belonging to American Society of Anaesthesiologist grade II posted for both elective and emergency lower segment caesarean section under Spinal Anaesthesia 
 
ExclusionCriteria 
Details  Patient not willing to participate in the study.
Allergic to local anaesthetic agent.
Patient BMI more than 30 kg per m2.
Height less than 145cm.
Contraindications to Spinal Anaesthesia (Coagulopathies, local infections) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesic effects:

It is noted considering the time of completion of the respective block procedure (I.E deposition of the required amount of local anaesthetic drug in to the desired plane) on each side as the reference point to the first rescue analgesia. 		 0mins,30mins,1hour,4hours,8hours,12hours,24hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time for first rescue analgesia and Comparing pain scores using visual analogue scale.  0mins,30mins,1hour,4hours,8hours,12hours,24hours 
 
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)   19/09/2025 
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="0" 
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  

This study compared two doses of clonidine as an adjuvant to ropivacaine in ultrasound-guided transversus abdominis plane (TAP) blocks for post-caesarean analgesia. Patients receiving the higher clonidine dose experienced longer-lasting pain relief and better analgesic effects, but with increased sedation and mild hemodynamic changes. The lower dose provided effective analgesia with fewer side effects but a shorter duration of pain control. Overall, the study suggests that while higher doses of clonidine enhance analgesia duration, the lower dose offers a safer balance between efficacy and side effects.

 
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