| 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
|
|
|
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
|
|
|
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. |