Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery

Sponsor

Muğla Sıtkı Koçman University (Other)

Overall Status

Completed

CT.gov ID

NCT04591119

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

36.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Chest Pain Coronary Artery Bypass Sternotomy	Procedure: Transversus Thoracic Muscle Plane Block Procedure: Parasternal Intercostal Plane Block	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial

Actual Study Start Date :

Oct 20, 2020

Actual Primary Completion Date :

Dec 20, 2020

Actual Study Completion Date :

Dec 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transversus Thoracic Muscle Plane Block (TTMPB) Group At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space.	Procedure: Transversus Thoracic Muscle Plane Block 40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space
Active Comparator: Parasternal Intercostal Block (PSIB) Group At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally.	Procedure: Parasternal Intercostal Plane Block 40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.
No Intervention: Control Group At the control group, no intervention for pain management will be done.

Arm

Intervention/Treatment

Active Comparator: Transversus Thoracic Muscle Plane Block (TTMPB) Group

At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space.

Procedure: Transversus Thoracic Muscle Plane Block

40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space

Active Comparator: Parasternal Intercostal Block (PSIB) Group

At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally.

Procedure: Parasternal Intercostal Plane Block

40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.

No Intervention: Control Group

At the control group, no intervention for pain management will be done.

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption [Postoperative 24th hour]
Tramadol consumption will be assessed by checking patient daily drug order records
Postoperative opioid consumption [Postoperative 1st, 4th and 12th hour]
Tramadol consumption will be assessed by checking patient daily drug order records

Secondary Outcome Measures

Behavioral Pain Scale [postoperative 1st and 4th hour]
A blinded nurse will assess postoperative pain while they are intubated at the 1st and 4th hour by using 3 subscale Behavioral Pain Scale which ranges from 3 (no pain) to 12 (maximum pain)
Numeric Rating Scale [Postoperative 12th and 24th hour]
A blinded nurse will assess postoperative pain during resting and movement at postoperative 12th and 24th hour by using Numeric rating scale at the extubated patient by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists physical status II-III
Elective coronary artery bypass graft surgery under general anesthesia

Exclusion Criteria:

American Society of Anesthesiologists physical status IV
Emergency surgery and redo surgery
Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
Allergy to any study drugs, local infection at the block site
Opioid abuse