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