FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/059673 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to compare the effect of dexmedetomidine and lignocaine on pain control after cardiac surgery  
Scientific Title of Study   Comparison of intravenous dexmedetomidine and lignocaine in combination with parasternal intercostal block on postoperative analgesia in adult patients undergoing cardiac surgery- A prospective randomized 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  Dr Preeti Prajapat 
Designation  Post Graduate Trainee 
Affiliation  All India Institute of Medical Science, Bhopal 
Address  Department of Anesthesiology and Critical Care, 3rd Floor Hospital building AIIMS Saket Nagar Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  8168618704  
Fax    
Email  preeti.jr2023@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, Bhopal 
Address  Department of Anesthesiology and Critical Care, AIIMS Saket Nagar, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, Bhopal 
Address  Department of Anesthesiology and Critical Care, AIIMS Saket Nagar, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Bhopal(Non funded) 
 
Primary Sponsor  
Name  Dr S R A N Bhushanam Padala 
Address  Department of Anesthesiology and Critical Care AIIMS Saket Nagar, Bhopal 
Type of Sponsor  Other [Guide( Assistant Professor)] 
 
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 Preeti  AIIMS Bhopal  Department of Anesthesiology and Critical Care and Department of Cardiothoracic and Vascular Surgery 3rd Floor, Hospital Building AIIMS Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH 		 8168618704

preeti.jr2023@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, Bhopal Institutional Human Ethics Committee- Student Research (IHEC-SR)   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  Intravenous Dexmedetomidine along with parasternal intercostal block  Group PD - Parasternal block + 0.5 mcg/kg dexmedetomidine loading dose over 15 min followed by 0.4 mcg/kg/hr. Parasternal block-0.20% bupivacaine 4ml in each intercostal space from 2nd to 6th on each side (total 40ml)  
Comparator Agent  Intravenous Lignocaine along with parasternal intercostal block   Group PL - Parasternal block + 1.5 mg/kg lignocaine(Preservative free) loading dose over 15 min followed by 1mg/kg/hr. Parasternal block-0.20% bupivacaine 4ml in each intercostal space from 2nd to 6th on each side (total 40ml)  
Comparator Agent  Intravenous normal saline along with parasternal intercostal block.  Group PS - Parasternal block + 10 ml 0.9% normal saline over 15 min followed by 5 ml/hr. Parasternal block-0.20% bupivacaine 4ml in each intercostal space from 2nd to 6th on each side (total 40ml) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65 years
2.All consenting patient with elective cardiac surgeries through median sternotomy using cardiopulmonary bypass.
 
 
ExclusionCriteria 
Details  1.Patients with preoperative cognitive impairment.
2.Patients on mechanical ventilation support or inotropes or intra-aortic balloon pulsation preoperatively
3.Patients with a history of previous cardiac surgery
4.Patients with LVEF <35%
5.Patients allergic to study drugs and addicted to narcotics
6.Patient with chronic liver and renal disease.
7.Patient with heart rate < 50 beats/minute
 
 
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 
To assess and compare dexmedetomidine and lignocaine infusions in combination with parasternal intercostal block on postoperative analgesic(Fentanyl and Tramadol) requirements in patients undergoing cardiac surgery.  24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the duration of postoperative mechanical ventilation in patients undergoing cardiac surgery after dexmedetomidine and lignocaine infusions in combination with parasternal intercostal block  12 hours postoperatively 
2. To compare the postoperative Visual Analogue Scale (VAS) pain scores in patients undergoing cardiac surgery after dexmedetomidine and lignocaine infusions in combination with parasternal intercostal block.  VAS score at first spontaneous eye opening and after that every 4 hourly (12,16,20,24 hr) postoperatively. 
3. To compare the intraoperative and postoperative hemodynamic stability in patients undergoing cardiac surgery after dexmedetomidine and lignocaine infusions in combination with parasternal intercostal block.  Four hourly after shifting to ICU (P0, P4,P8, P12,P16, P20,P24) 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   13/12/2023 
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 Yet Recruiting 
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             Despite the use of multimodal analgesic regimes, minimally invasive surgical procedures, and better recovery programs, postoperative pain management remains inadequate. Acute postoperative pain impedes patients’ functional recovery and is one of the most important predictors of the shift to chronic postsurgical pain. When compared to other major surgical operations, cardiac surgery is linked with significant pain. Postoperative day (POD) 1 and 2 are the most painful days following heart surgery. In addition to the patients’ experience, postoperative pain following heart surgery has a negative impact on the result. Postoperative tachycardia, hypertension, arrhythmias, and myocardial ischemia are all common. The majority of postoperative pain treatment procedures are based on opioids, which have a dose-dependent analgesic effect.
         Although multimodal analgesia was employed in 86% of patients in a recent large cohort trial, practically all patients got an opioid for postoperative pain. High dosages of opioids are well recognized to cause respiratory depression, drowsiness, postoperative nausea and vomiting (PONV), pruritus, urine retention, constipation and ileus , hyperalgesia, and allodynia. All of these factors can hinder patients’ functional recovery, lengthen hospital stays, and raise health-care expenses, as well as result in poor postoperative pain control and the transition to chronic pain. As a result, there is still a need to test adjuvant treatments that might minimize perioperative opioid usage.
        In the Enhanced Recovery After Surgery era, parasternal intercostal nerve block has been proposed to improve pain control and reduce opioid use in patients undergoing cardiac surgery. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, appear potential as adjuvants for this purpose. Dexmedetomidine has a relatively high ratio of α2/α1 activity (1620:1 against 220:1 for clonidine) and is thus regarded a complete agonist of the α2 receptor. This may result in more strong sedative effects without the undesirable cardiovascular consequences associated with α1 receptor activation. Dexmedetomidine, unlike gamma-aminobutyric acid agonists and opiates, has a distinct mode of action. It has sedative, anxiolytic, sympatholytic, anti-delirious, and analgesic sparing actions while causing minimal respiratory depression. Currently, intravenous lidocaine is utilized as a peri-operative analgesic in a variety of settings, including the operating room, recovery room, intensive care unit (ICU), and surgical ward.
        The purpose of this study was to see how dexmedetomidine and lidocaine affected postoperative pain and analgesic consumption, as well as important functional recovery characteristics like bowel function, mobilization, sleep quality, and other parameters (like PONV and sedation) in patients undergoing cardiac surgery. A standard anesthesia technique will be followed in all the patients included in the study. Well informed written consent will be taken from the patient included in the study. All the records will be confidential, and the patient identity would be known to the chief investigator and would not be released to anybody else. Participation in the study will be voluntary and refusal to participate will not influence care of the participants in the hospital anyway.
 
Close