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CTRI Number  CTRI/2026/02/103946 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 13/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to evaluate pain relief after heart surgery using erector spinae block with levobupivacaine with and without dexmedetomidine 
Scientific Title of Study   COMPARISION OF EFFICACY OF POST OPERATIVE ANALGESIA BY ULTRASOUND GUIDED BILATERAL ERECTOR SPINAE BLOCK USING 0.25 % LEVOPBUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN ELECTIVE ADULT CARDIAC SURGERIES- RANDOMIZED DOUBLE BLINDED 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  SHAIK NISA SHAFAQH 
Designation  POST GRADUATE 
Affiliation  Assistant professor 
Address  Door no 21-3-67, bhashyakarla street, opposite I.n.m high school, nellore
staff quarters,narayana medical college doctors residential campus, nellore rural, chinthareddy palem, nellore 524003,Andhra pradesh, india.
Nellore
ANDHRA PRADESH
524003
India 
Phone  9959665543  
Fax    
Email  Shaiknisa7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHAIK NISA SHAFAQH 
Designation  POST GRADUATE 
Affiliation  Student 
Address  Door Number 21-3-67, Bhashyakarla street, Opposite P.N.M High school, Nellore-524001,Andhra Pradesh, India

Nellore
ANDHRA PRADESH
524003
India 
Phone  9959665543  
Fax    
Email  Shaiknisa7@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHAIK NISA SHAFAQH 
Designation  POST GRADUATE 
Affiliation  Student 
Address  door number 21-3-67, bhashyakarla street, opposite p.n.m high school, nellore, Andhra Pradesh-524001

Nellore
ANDHRA PRADESH
524003
India 
Phone  9959665543  
Fax    
Email  Shaiknisa7@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SHAIK NISA SHAFAQH 
Address  D.no 21/452 ( new 21-3-67 ) Bhashyakarla street, Opposite p.n.m high school, NELLORE, Andhra Pradesh Nellore-524001 India 
Type of Sponsor  Other [Self] 
 
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 
Shaik Nisa  NARAYANA MEDICAL COLLEGE  CHINTHAREDDYPALEM, NELLORE - 524003, ANDHRA PRADESH.
Nellore
ANDHRA PRADESH 		 9959665543

shaiknisa7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NARAYANA MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Patients will be randomized into two groups. Group LP will receive ultrasound-guided bilateral erector spinae plane block with 0.25% levobupivacaine (60 mL total). Group LD will receive ultrasound-guided bilateral erector spinae plane block with 0.25% levobupivacaine plus dexmedetomidine (20 µg) (60 mL total). Blocks will be performed bilaterally at T5 and T7 levels after induction of general anaesthesia under ultrasound guidance  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective cardiac surgeries requiring general anaesthesia
Ejection fraction more than 40 percent 
 
ExclusionCriteria 
Details  Refusal of patient, age lessthan 18 years, inflammatory or infection at injection site, allergy to local anaesthetics, altered coagulation profile, spine deformities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perioperative haemodynamic changes, Requirement of opioids and muscle relaxants, Total duration of postoperative analgesia (up to 24 hours)  Haemodynamic variables were recorded preoperatively, and at 5, 15, 30, and 60 minutes following block administration, and subsequently at 2, 3, and 4 hours. Postoperative assessments including pain scores (VAS), sedation scores, opioid consumption, and haemodynamic parameters were obtained immediately after extubation, and at 2, 4, 6, 8, 12, and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes including VAS pain scores, haemodynamic parameters, sedation scores, opioid consumption, and inotropic requirement will be assessed in the immediate postoperative period and at 2, 4, 6, 8, 12, and 24 hours. Duration of mechanical ventilation and ICU stay will be recorded until ICU discharge.  after extubation, and at 2, 4, 6, 8, 12, and 24 hours. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   03/03/2026 
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="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shaiknisa7@gmail.com].

  6. For how long will this data be available start date provided 13-02-2026 and end date provided 13-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Postoperative pain following cardiac surgery is multifactorial, arising from sternotomy, tissue trauma, drains, and thoracic cage retraction. Adequate analgesia is essential for enhanced recovery, early mobilization, and reduction of opioid consumption. The erector spinae plane (ESP) block has emerged as a safe and effective regional analgesic technique in cardiac surgical patients. Dexmedetomidine, when used as an adjuvant to local anesthetics, may prolong analgesic duration and improve pain control.

This prospective, randomized, double-blinded study aims to compare the analgesic efficacy of ultrasound-guided bilateral ESP block using 0.25% levobupivacaine with and without dexmedetomidine in adult patients undergoing elective cardiac surgery.

Fifty patients will be randomized into two groups. Group LP will receive bilateral ESP block with 0.25% levobupivacaine, while Group LD will receive 0.25% levobupivacaine with dexmedetomidine (20 µg).

The primary outcomes include total opioid consumption and time to first rescue analgesia within 24 hours postoperatively. Secondary outcomes include postoperative pain scores (VAS), haemodynamic parameters, sedation scores, duration of mechanical ventilation, ICU stay, and adverse effects.

The study is designed to evaluate whether dexmedetomidine provides superior postoperative analgesia when used as an adjuvant in ESP block for cardiac surgical patients.

 
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