| CTRI Number |
CTRI/2022/07/044245 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain relief after operation by medication through tube placed beneath the skin in cardiac
surgical patients |
|
Scientific Title of Study
|
Effect of ropivacaine infiltration through pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LSNAGASWETHA |
| Designation |
DM student |
| Affiliation |
AIIMS delhi |
| Address |
Department of Cardiac anesthesia, first floor, CN centre, AIIMS New delhi
Department of cardiac anesthesia, first floor,CN Centre,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8297389386 |
| Fax |
|
| Email |
swethasweety634@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfSandeep Chauhan |
| Designation |
Professor and Head of the department AIIMS New delhi |
| Affiliation |
CN center,AIIMS New Delhi |
| Address |
Department of cardiac anesthesia, first floor,CN centre,AIIMS New delhi
Department of cardiac anesthesia first floor CN Centre,AIIMS New delhi
New Delhi
DELHI
110029
India |
| Phone |
9873729366 |
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
LSNAGASWETHA |
| Designation |
DM student |
| Affiliation |
AIIMS delhi |
| Address |
Department of cardiac anesthesia, first floor,CN centre,AIIMS New delhi
Department of cardiac anesthesia, first floor,CN centre,AIIMS New delhi
New Delhi
DELHI
110029
India |
| Phone |
8297389386 |
| Fax |
|
| Email |
swethasweety634@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac anesthesia,first floor,CN Centre,AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
LSNagaswetha |
| Address |
AIIMS,new delhi |
| Type of Sponsor |
Other [By principal investigator ] |
|
|
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 |
| LSNaga swetha |
AIIMS |
Department of Cardiac anesthesia,first floor,CN centre,AIIMS delhi
New Delhi
DELHI |
8297389386
swethasweety634@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
Placebo |
Control group |
| Intervention |
Ropivacaine drug infiltration |
Ropivacaine local anaesthetic drug is administered through pre-sternal multi-orifice catheter for post-sternotomy pain relief after surgery in postoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. age groups 18-65 years of either sex 2. category 1 or 2 under CARE score (Cardiac Anaesthesia Risk Evaluation score) are included in the study viz. coronary artery disease with TVD and normal LV function, all valve replacement surgeries, ASD and VSD closure |
|
| ExclusionCriteria |
| Details |
1. emergency surgery 2. Redo surgeries 3. Preoperative inotropic support 4. preoperative poor left ventricular function (EF <40%) 5. clinically significant kidney or liver disease 6. COPD patients, uncontrolled DM 7. morbidly obese patients 8. Low cardiac output syndrome 9. patients allergic to local anaesthetics 10. preexisting coagulopathy 11. postoperative hemodynamic instability 12. If surgeon refuses |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of ropivacaine infiltration by pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery based on Visual Analog Score (VAS) and rescue analgesic consumption. |
Visual analog scale assessment for 48hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to extubation ➢ Postoperative respiratory parameters ➢ Length of ICU stay ➢ Incidence of wound infection |
171 |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
25/07/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cardiac surgery induces severe postoperative pain, resulting in impairment of pulmonary function, increased duration of hospital stay with increased morbidity and mortality1. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis and prolongs recovery2 . A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days2 . Sternotomy, rib retraction, conduit harvest and drain tubes are some of the sources of pain in cardiac surgery1 . The most often used analgesics in these patients are parenteral opioids which can lead to undesirable respiratory depression, nausea and vomiting2Therefore, we are planning a prospective, randomised, controlled, study on the efficacy and safety of infusing long-acting local anaesthetic drugs vs intermittent boluses of local anaesthetic administration into the median sternotomy wound in adult patients after cardiac surgery. we hypothesized that this intermittent bolus administration of local anaesthetic would significantly improve pain control as that of continuous infusion, as evidenced by the reduced need for postoperative systemic analgesic |