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CTRI Number  CTRI/2026/02/103173 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of transversus thoracis block versus intercostal block for pain relief after open heart surgeries. 
Scientific Title of Study   A randomized comparative study for the efficacy of bilateral transversus thoracis muscle plane block versus parasternal intercostal block for perioperative opioid consumption in patients undergoing cardiac surgeries. 
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 Reema Meena 
Designation  Senior Professor 
Affiliation  Sawai Mansingh Medical College, Jaipur 
Address  Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302001
India 
Phone  9413237117  
Fax    
Email  reemadr.rn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reema Meena 
Designation  Senior Professor 
Affiliation  Sawai Mansingh Medical College, Jaipur 
Address  Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302001
India 
Phone  9413237117  
Fax    
Email  reemadr.rn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Singh 
Designation  PG Student 
Affiliation  Sawai Mansingh Medical College, Jaipur 
Address  Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302001
India 
Phone  7568998621  
Fax    
Email  swatisingh1142@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India-302001 
 
Primary Sponsor  
Name  Sawai Mansingh Medical College and Hospital 
Address  Department of Anaesthesiology, Second Floor, OT Complex, Dhanwantri Building, SMS Hospital, Jaipur 
Type of Sponsor  Government medical college 
 
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 Reema Meena  SMS Medical College and Hospital  Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN 
09413237117

reemadr.rn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College And Attached Hospitals, Jaipur  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 
Comparator Agent  Comparison of the efficacy of the above two blocks for perioperative opioid consumption in patients undergoing valvular open heart surgeries.  Comparison in the perioperative opioid requirement (fentanyl dose in micrograms) between the two groups upto 48 hours, time for need of first dose of rescue analgesia (in hours) and difference in VAS scores in the post operative period between the two groups.  
Intervention  Group A= Bilateral transversus thoracis muscle plane block  Patients undergoing valvular cardiac surgery under GA and receiving bilateral USG guided transversus thoracis muscle plane block between internal intercostal and transversus thoracis muscles with 40 ml 0.5 percent Ropivacaine with adjuvant Fentanyl 25 micrograms (20 ml each side) before incision and local infiltration of 10 ml 0.5 percent Ropivacaine on surgical drainage sites at the end of the surgery. Intraoperative opioid requirement will be assessed through BIS monitoring and for post operative analgesia fentanyl will be given through intravenous route with patient controlled intravenous analgesia pump with a background infusion of fentanyl (25 micrograms per ml) at the rate of 1 ml per hour for 48 hours. 
Intervention  Group B= Bilateral parasternal intercostal block  Patients undergoing valvular cardiac surgery under GA and receiving bilateral parasternal intercostal block with 40 ml 0.5 percent Ropivacaine with adjuvant Fentanyl 25 micrograms 4 ml in each space from 2nd to 6th intercostal space on each side before incision and local infiltration of 10 ml 0.5 percent Ropivacaine on surgical drainage sites at the end of the surgery. Intraoperative opioid requirement will be assessed through BIS monitoring and for post operative analgesia fentanyl will be given through intravenous route with patient controlled intravenous analgesia pump with a background infusion of fentanyl (25 micrograms per ml) at the rate of 1 ml per hour for 48 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients giving informed written consent.
2. Patients of age 18 years to 70 years scheduled for elective open heart valvular surgery via median sternotomy.
3. Subjects with ASA grade 2 to 3. 
 
ExclusionCriteria 
Details  1. Patients taking part in any other study.
2. Patients with history of opioid abuse.
3. Allergic to local anesthetics.
4. Impaired cerebral functions.
5. Inability to understand or operate the PCA pump.
6. Patients with Body Mass Index more than 30 kg per m2.
7. Patients with local site infections or burns. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the difference in perioperative opioid requirement between the two groups.  Assessed immediately, 2,4,6,12,18,24,30,36,42 and 48 hours post extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess and compare the time for need of first dose of rescue analgesia (Injection Fentanyl intravenously in both groups).
2. To assess the difference in postoperative Visual Analogue Scale between the two groups.
3. To assess and compare hemodynamic response between the study groups.
4. To assess and compare postoperative PEFR after extubation in both the study groups.
5. Side effects and complications if any in both groups. 
Assessed immediately, 2,4,6,12,18,24,30,36,42 and 48 hours post extubation. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   16/03/2026 
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="6"
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   After obtaining approval from the institutional ethics committee and written informed consent; patients scheduled for valvular cardiac surgery under general anesthesia satisfying inclusion criteria will be enrolled in the study.
At the time of pre op visit, patients will be familiarized with a 10 cm visual analogue scale for pain assessment. Patient will be given Tab Alprex 0.5 mg previous night. NBM status, PAC and consent will be checked in the operating room. Routine vital monitors will be attached for ECG, SpO2, EtCO2, entropy. Peripheral IV line, IJV central line, arterial line for invasive BP monitoring will be secured under local anesthesia and baseline vitals will be noted before induction. After randomization, patient (n=60) will be allocated into specific group as per study protocol by sealed envelope method.
Patient will be induced with Inj. Midazolam 0.05 mg per kg, Inj. Fentanyl 4 micrograms per kg, Inj. Etomidate 0.3 mg per kg, Inj. Rocuronium 0.9 mg per kg to facilitate endotracheal intubation . Patient will be mechanically ventilated by 100 percent O2 with tidal volume 6 to 8 ml per kg for 3 minutes and under direct laryngoscopy patient will be intubated with appropriate size ETT. Bilateral air entry will be checked and tube will be fixed. EtCO2 35 to 45 mm Hg will be maintained by adjusting respiratory rate of 12 to 16 breaths per minute.
In Group A, Bilateral transversus thoracis muscle plane block, patients will receive bilateral USG guided block immediately after induction and intubation. The block will be executed with aseptic technique. The block will be given at T4 to T5 intercostal space bilaterally with a 22 G atraumatic spinal needle using 40 ml 0.5 percent Ropivacaine with adjuvant Fentanyl 25 micrograms  (20 ml each side) before incision and local infiltration of 10 ml 0.5 percent Ropivacaine on surgical drainage sites at the end of the surgery.
In Group B, Parasternal block, patients will receive bilateral USG guided block immediately after induction and intubation with aseptic technique. The block will be given between pectoral major and intercostal muscles, proximal to the sternum from 2nd to 6th intercostal space with 40 ml 0.5 percent Ropivacaine with adjuvant Fentanyl 25 micrograms (4 ml in each space from 2nd to 6th intercostal space on each side) before incision and local infiltration with 10 ml 0.5 percent Ropivacaine at surgical drainage sites at the end of the surgery.
In both the groups, patients will be shifted to ICU with ETT in situ at the end of the surgery.
In both the groups IV Fentanyl ( 25 micrograms per ml) at a basal infusion rate of 1 ml per hour and a bolus of 1 ml given by the patient him/herself whenever needed with a lockout interval of 15 minutes for 48 hours after extubation. If the patient will still experience pain ( VAS more than equal to 4), then Inj. Tramadol 50 mg will be given.
Fentanyl requirement, VAS score and hemodynamic parameters will be assessed immediately, 2, 4, 6, 12, 18, 24, 30, 36. 42 and 48 hours post extubation. Side effects or complications if any will be noted. End point of the study will be 48 hours after extubation.
 
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