| CTRI Number |
CTRI/2024/04/065343 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Effect of Transverse Thoracis Muscle Plane Block on requirement of pain medication during and after the surgery |
|
Scientific Title of Study
|
A Randomised controlled study for efficacy of bilateral transverse thoracis muscle plane block on perioperative requirement of fentanyl in patients undergoing cardiac surgery |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Attached hospitals |
| Address |
CSOT, Department of Anesthesia, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
Dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Attached hospitals |
| Address |
CSOT, Bangar Parisar, SMS Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
Dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Mittal |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and Attached hospitals |
| Address |
Dept of Anaesthesiology, SMS Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9041017407 |
| Fax |
|
| Email |
harshmits01@gmail.com |
|
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Source of Monetary or Material Support
|
| SMS Medical College and attached hospitals, Jaipur, Rajasthan, India. Pincode: 302004 |
|
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Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care SMS Medical College and Attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur, Rajasthan, India Pincode: 302004 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsh Mittal |
SMS Hospital |
CSOT, First Floor, Bangar Parisar, SMS Hospital
Jaipur
RAJASTHAN |
9041017407
harshmits01@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Comittee, SMS Medical College and attached hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anesthesia |
No Block will be given to control group. Post operative analgesia will be provided with 10mcg/hr fentanyl for 48 hours |
| Intervention |
Transverse Thoracis Muscle Plane Block (TTMB) |
Transverse Thoracis Muscle Plane Block will be performed bilaterally under USG guidance with patient in supine position after induction of General Anesthesia but before surgeon makes the incision, using 40 ML 0.5% Ropivacaine + 25 mcg Fentanyl. Post operative analgesia will be provided with 10mcg/hr fentanyl for 48 hours |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing planned cardiac surgery via median sternotomy, patient giving informed consent for study, weight 40 to 75 kg, ASA PS grade 2 or 3 |
|
| ExclusionCriteria |
| Details |
Patient undergoing CABG using Internal Mammary Artery, Non-consenting patient, patient should not be a part of other study, allergic to study drugs, endocrine, metabolic, neurological and psychiatric disorders, patients on anti coagulant drugs or coagulopathy |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean Dose of Fentanyl Intraoperative and postoperative period |
At end of surgery, 48 hours postoperative |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Hemodynamic Variables - mean heart rate, mean systolic, diastolic and mean blood pressures |
Pre operative, 2 mins after intubation, 2 mins after TTMB, 15 min, 30 min, every 15 mins till patient goes on Cardiopulmonary bypass, 0 mins after coming off pump, every 15 mins till surgery is complete. Immediate Post operative, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs |
| Mean PEFR at time of extubation |
At time of extubation |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
At the time of pre-operative visit, patients will be familiarised with the procedure, a 11 point Numeric Rating Scale (NRS) for pain assessment (0 = no pain at all, 10 = worst imaginable pain) and use of PCA pump.On arrival to the operation theatre, fasting status, written informed consent and PAC will be checked. All routine monitors will be attached; HR, SBP, DBP, MAP, ECG and Spo2 will be noted. Intravenous line with 18G cannula will be secured and i.v. fluid RL will be started at 5ml/kg/hour. Internal jugular vein (IJV) and femoral arterial cannulation will be done under local anesthesia. Patient will be induced with Inj. Midazolam i.v. (0.05mg/kg), Inj. Fentanyl i.v. (3/ μgkg), Inj.Etomidate i.v. (0.3mg/kg), Inj. Rocuronium i.v. (0.9mg/kg) will be given as a muscle relaxant to facilitate endotracheal intubation. Patient will be ventilated with 100% oxygen for 3 minutes and under direct laryngoscopy patient will be intubated with the appropriate size E.T.T. Bilateral air entry will be checked and tube will be fixed. ULTRASOUND GUIDED BLOCKS: TTMPB will be performed in supine position under sterile conditions after patient is anaesthetised before the commencement of the surgical procedure. A high frequency 12 MHz linear ultrasound probe with a sterile sheath placed 1 cm lateral to the sternal border, T4-T5 intercostal space identified under ultrasound guidance in a parasagittal view and needle inserted in plane to the probe. Transversus Thoracis Muscle Plane block will be performed in patients of Group A at T4-T5 intercostal space bilaterally with a 22G atraumatic spinal needle using 40ml 0.5% Ropivacaine with adjuvant Fentanyl 20 mcg (20 ml each side) 10 ml of 0.5 % Ropivacaine is infilterated around the pleural chest tube sites in both the groups . Heart rate, Systolic, Diastolic and mean Blood pressure and CVP will be recorded preoperatively as baseline, just after block, 5 min after block, just after intubation, 5 min after intubation and every 15 min thereafter. The surgery will be allowed to commence and anesthesia will be maintained will 100% oxygen, 1% sevoflurane and intermittent Inj. Vecuronium i.v. (0.01mg/kg/half an hourly), injection midazolam 0.01mg/kg hourly , The BIS guided monitoring will be used to evaluate intraoperative pain, BIS monitoring measures the depth of anesthesia and facilitates anesthetic titration, BIS will be maintained 40-60 during surgery if score more than 60 injection Fentanyl 1mcg/kg IV dose will be repeated . Total intraoperative Fentanyl will be noted. Patient will be shifted to ICU with IPPV and taken on ventilator. As per protocol of our hospital injection paracetamol 1 gm IV will be given before patient is shifted to ICU. When patient is conscious, hemodynamically stable and fulfills the criteria of extubation, the patient will be, the time of extubation will be noted. After extubation, NRS (Numeric Rating Scale) pain score will be noted. In ICU, Patient Controlled Analgesia (PCA) pump will be started with Fentanyl (5 mcg/ml) at a basal infusion rate of 2 ml/hr and a bolus 2ml (10 mcg) whenever needed by the patient him/herself with a lockout interval of 15 mins upto 48 hours after extubation. If patient needs rescue analgesia within lockout interval Inj Tramadol (50mg) IV bolus will be given.
H0 (NULL HYPOTHESIS): There is no significant difference in the mean of total dose requirement of Fentanyl in 48 hours with Transverse Thoracis Muscle Plane Block (TTMPB) as compared to the control group. H1 (ALTERNATE HYPOTHESIS): There is a significant difference in the mean of total dose requirement of Fentanyl in 48 hours with TTMPB as compared to the control group.
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