| CTRI Number |
CTRI/2024/11/076280 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Patients having heart surgery received a nerve block in their chest with a medicine called ropivacaine, sometimes combined with another medicine called dexmedetomidine, to help manage pain after surgery. |
|
Scientific Title of Study
|
Efficacy of dexmedetomidine as an adjunct to Ropivacaine in pectoral nerve block in cardiac surgery .A prospective randomized double blinded trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Saha |
| Designation |
Junior resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand.
Ranchi
JHARKHAND
834009
India |
| Phone |
7365025770 |
| Fax |
|
| Email |
sushmitasaharims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shio Priye |
| Designation |
Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand.
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Sinha |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of medical sciences |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand.
Ranchi
JHARKHAND
834009
India |
| Phone |
7860337418 |
| Fax |
|
| Email |
drniteshsinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences,Ranchi,.Jharkhand.Pincode 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences,Ranchi,Jharkhand.Pincode 834009.India |
| Type of Sponsor |
Government medical college |
|
|
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 Sushmita Saha |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
Department of
Anesthesiology
RIMS, Bariatu, Ranchi,
Jharkhand,
India-834009
Ranchi
JHARKHAND
Ranchi
JHARKHAND |
7365025770
sushmitasaharims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pectoralis block with only Ropivacaine. |
20ml of 0.125% ropivacaine given bilaterally by pectoralis block before extubation in patients undergoing cardiac surgery.Block is given before shifting the patient out of operation theatre and pain scores recorded for 24hrs post extubation. |
| Intervention |
Pectoralis block with Ropivacaine -Dexmedetomidine |
20ml of drug made with 0.125% ropivacaine and 1mcg/kg dexmedetomidine given before extubation on bilateral side in patients undergoing cardiac surgery.Block is given before shifting patient out od operation theatre and pain scores recorded for 24hrs post extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient giving consent
2.Age between 18-60years
3.ASA II & II
4.Patients undergoing elective cardiac surgery.(MVR,ASD)
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
Patients with history of allergy to study drugs(ropivacaine,dexmedetomidine).
Patients having abnormal coagulation profile
Pre operative haemodynamic instability.(Congestive heart failure ,uncontrolled AF).
Patients with moderate to severe PAH,LVEF less than 40%.
|
|
|
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 |
1.Pain scores (VAS two hourly) in first 24 hours after extubation .
2.Total fentanyl(0.5mics/kg) consumption in first 24 hours.
|
1.Pain scores (VAS two hourly) in first 24 hours after extubation .
2.Total fentanyl(0.5mics/kg) consumption in first 24 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of first rescue analgesia.
2.Length of icu stay.
3.Duration of mechanical ventilation after surgery.
4.Hemodynamic variables two hourly (MAP and heart rate).
5.Drug related side effects(delirium and sedation).
|
Hemodynamic variables 2hourly (MAP and Heart rate) |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ultra sound guided pectoralis block is a novel technique used to relive pain in patients undergoing anterior chest wall surgery like cardiac surgery.Use of a local anaesthetic drug like ropivacaine along with dexmedetomidine may prove to be good fpr post operative pain in cases of cardiac surgery. |