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CTRI Number  CTRI/2021/09/036938 [Registered on: 28/09/2021] Trial Registered Prospectively
Last Modified On: 20/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Placement of 2 thin tubes at chest for pain control after heart surgery 
Scientific Title of Study   Efficacy of bilateral parasternal subpectoral catheters(sternal block)for postoperative analgesia following sternotomy-A randomized double blinded cross over clinical trial 
Trial Acronym  parasternal catheters 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sivashanmugam 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth Deemed to be University 
Address  Department of anaesthesiology 2nd floor hospital block mahatma gandhi medical college hospital pillayarkuppam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9442505567  
Fax    
Email  drsiva95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana Areti 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anaesthesiology 2nd floor hospital block mahatma gandhi medical college hospital pillayarkuppam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8374237095  
Fax    
Email  archanaareti@mgmcri.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Areti 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anaesthesiology 2nd floor hospital block mahatma gandhi medical college hospital pillayarkuppam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8374237095  
Fax    
Email  archanaareti@mgmcri.ac.in  
 
Source of Monetary or Material Support  
Department of anaesthesiology Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth Deemed to be University 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Mahatma Gandhi Medical college and research institute ,Pillayarkuppam,Pondicherry 607402 
Type of Sponsor  Research institution and hospital 
 
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 Sivashanmugam  Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth Deemed to be university  Department Of Anaesthesiology Pillaiyarakuppam
Pondicherry
PONDICHERRY 
9442505567

drsiva95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics commitee of Mahatma Gandhi Medical college  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local Anaesthetic  20ml 0.2% Ropivicaine with 30mcg Og Inj. Clonidine through each of the sub pectoral catheters 
Comparator Agent  Placebo  20ml normal saline through each of the sub pectoral catheters 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  aged 18-80 years & ASA II-III 
 
ExclusionCriteria 
Details  redo Sternotomy, requiring higher inotropic support and prolonged ventilatory support, difficult to wean from CPB, contraindications for local anesthetics and unable to comprehend VAS score 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Morphine Consumption – Total dose of morphine consumption
 
First and second postoperative day 
 
Secondary Outcome  
Outcome  TimePoints 
2.Efficacy of Pain relief
a.Cumulative dosage of rescue analgesic
b.Static Analgesia-NRS at rest
c.Dynamic Analgesia – NRS during cough and while performing Incentive spirometry
d.Patient Satisfaction score on Likert scale
 
First and second postoperative day 
3.Functional outcome of pain relief
a.Quality of Cough
b.PEFR in L/min
c.Incentive spirometry
 
First and second postoperative day 
4.Complications   First and second postoperative day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients undergoing elective cardiac surgical procedures through median sternotomy at MGMCRI ,after obtaining ethical committee approval and informed consent from patients  , will receive General anaesthesia with invasive monitoring according to discretion of attending anaesthesiologist. The Inclusion criteria include patients aged 18-80 years & ASA II-III .Exclusion criteria includes patients -redo Sternotomy, requiring higher inotropic support and prolonged ventilatory support, difficult to wean from CPB, contraindications for local anesthetics and unable to comprehend VAS score. 30 patients (15 per group) satisfying inclusion and exclusion criteria will be recruited by continuous sampling and Bilateral parasternal sub pectoral catheter will be inserted under ultrasound guidance after skin closure.Group A (15 patients) will receive 10 ml of Local anaesthesia on POD 1 ,10 ml of NS on POD 2 .Group B 15 patients will receive 10 ml of NS on POD 1 ,10 ml ofLocal anaesthesia  on POD 2 .Study Parameters will be assessed on 9am 1pm 6pm 10pm on POD 1 and POD 2 .

·        Efficacy of Pain relief: Static and dynamic NRS, Rescue analgesic consumption, Patient satisfaction score.

                                                                                                           Â·         Functional outcome of pain relief: Quality of cough, PEFR, No. of balls lifted during spirometry

                                                                                                           Â·         Complications: Sedation, LAST, wound infection, nausea, vomiting

Rescue analgesics will be provided if NRS >5

(1)Inj Ketorolac 30 mg iv with minimum interval of 4 hour between doses and max 90 mg

(2) Inj Morphine after 20 minutes of Ketorolac- 3 mg with minimum 15 minutes between doses and a maximum of 9 mg /day

All patients Patients will be shifted to CTVS ICU for overnight elective ventilation. On POD 1 6am study regimen will be injected and repeated 6th hourly till 48 hrs.


 
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