| CTRI Number |
CTRI/2025/10/096333 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing chest and tube pain after open heart surgery: comparing two regional block methods for better pain relief |
|
Scientific Title of Study
|
Comparative Efficacy of Regional Blocks within a Transitional Pain Service Model: TTPB with SAPB versus TTPB with Intercostal Nerve Block for Post-Sternotomy and Intercostal drain Pain – A Randomized Controlled 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 |
Shubhi kapuskar |
| Designation |
Senior resident |
| Affiliation |
NSCB MEDICAL COLLEGE JABALPUR |
| Address |
C 302 Jasuja Tower Jasuja City Colony phase 3, dhanwantri nagar, Jabalpur
Department of anaesthesia, super specialty hospital, NSCB medical college Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8319538372 |
| Fax |
|
| Email |
shubhikapuskar1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwanath Bhargav Mohire |
| Designation |
Professor |
| Affiliation |
NSCB MEDICAL COLLEGE JABALPUR |
| Address |
SWASTIK TOWER flat no 1009 swastik grand C BLOCK GARHA JABALPUR
Department of anaesthesia, super specialty hospital, NSCB medical college Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8744090856 |
| Fax |
|
| Email |
vbm201a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhi kapuskar |
| Designation |
Senior resident |
| Affiliation |
NSCB MEDICAL COLLEGE JABALPUR |
| Address |
C 302 Jasuja Tower Jasuja City Colony phase 3, dhanwantri nagar, Jabalpur
Department of anaesthesia, super specialty hospital, NSCB medical college Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8319538372 |
| Fax |
|
| Email |
shubhikapuskar1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Super Specialty Hospital,NSCB MEDICAL COLLEGE, JABALPUR,PINCODE 482003,MADHYA PRADESH,INDIA |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| 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 |
| Shubhi Kapuskar |
Super Speciality Hospital, NSCB Medical College |
Department of Anaesthesia, 5th floor,Room no 1
Jabalpur
MADHYA PRADESH |
8319538372
shubhikapuskar1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, NSCB medical college Jabalpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound-guided transversus thoracic plane block (TTPB) combined with serratus anterior plane block (SAPB). |
At the completion of cardiac surgery, while the patient remains intubated under general anaesthesia,blocks will be performed. Group A (TTPB + SAP) will receive a Transversus Thoracic Plane Block (TTPB) and Serratus Anterior Plane Block (SAP). Under aseptic precautions, with the patient in a supine position, USG guided TTPB will be performed near the sternum at the fourth intercostal space to identify the transversus thoracis muscle plane, and 20 ml of 0.25 percent Bupivacaine will be injected. For SAP, the probe will be placed in the mid-axillary line at the fifth rib level and 20 ml of 0.25 percent Bupivacaine will be administered. |
| Comparator Agent |
Ultrasound-guided transversus thoracic plane block (TTPB) combined with intercostal nerve block (ICNB). |
At the completion of cardiac surgery, while the patient remains intubated under general anaesthesia,blocks will be performed.
Group B (TTPB + ICNB) will receive a Transversus Thoracic Plane Block (TTPB) and Intercostal nerve block (ICBN). Under aseptic precautions, with the patient in a supine position, USG guided TTPB will be performed near the sternum at the fourth intercostal space to identify the transversus thoracis muscle plane, and 20 ml of 0.25 percent Bupivacaine will be injected.
Additionally, USG guided Intercostal Nerve Blocks (ICNB) will be performed in the third to sixth intercostal spaces on each side using an in-plane technique with 3 ml of 0.25 percent bupivacaine per level, targeting the intercostal space. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Elective cardiac surgery via median sternotomy
Extubated within 24 hour
|
|
| ExclusionCriteria |
| Details |
Refusal to participate
Coagulopathy
Local infection at block site
Allergy to local anaesthetic
Emergency re exploration
Hemodynamic instability post surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain intensity, measured using a validated pain scale (e.g.Visual Analogue Scale [VAS]) at rest and on coughing/movement over the first 24–48 hours after surgery. |
After extubation
30 min post extubation
1 hour post extubation
2 hour post extubation
3 hour
6 hour
12 hour
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Opioid consumption (e.g., total tramadol-equivalent dose in the first 24–48 hours).
2. Time to first rescue analgesia after block.
3. Incidence of postoperative nausea and vomiting (PONV).
4. Duration of ICU/hospital stay.
5. Block-related complications (pneumothorax, local anesthetic toxicity, hematoma, etc.).
6. Patient satisfaction scores regarding postoperative analgesia.
7. Functional recovery markers (deep breathing, incentive spirometry, early ambulation if relevant). |
Post extubation 24 hour
During icu stay
During follow up |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="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
|
This study is a prospective, randomized, active-controlled, parallel-group interventional trial designed to evaluate the comparative efficacy of regional anesthesia techniques within a transitional pain service model for patients undergoing median sternotomy with intercostal drain placement. Patients will be randomized to receive either transversus thoracic plane block (TTPB) combined with serratus anterior plane block (SAPB) or TTPB combined with intercostal nerve block (ICNB). The primary outcome is postoperative pain intensity (Numeric Rating Scale, at rest and on coughing) over the first 24 hours after surgery. Secondary outcomes include cumulative opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting, block-related complications, patient satisfaction, and length of ICU/hospital stay. Pain scores and analgesic requirements will be assessed at multiple time points up to 48 hours postoperatively, with follow-up at 7 and 30 days for safety and persistent pain assessment. The trial aims to determine which block combination provides superior analgesia and enhanced recovery, potentially guiding best practices in post-sternotomy pain management within a structured transitional pain service model. |