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Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery

Primary Purpose

Pain, Postoperative, Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Single-injection, ultrasound-guided bilateral PIF block.

Single-injection, ultrasound-guided bilateral TTMP block.

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Pain, Postoperative, Surgery, Cardiac, Nerve, Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
BMI <35 kg / m2

Exclusion Criteria:

Emergent surgeries, redo cases, minimally invasive procedures
Patients who do not want to participate
Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
Hypersensitivity or history of allergies to local anesthetics
Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
LVEF <30
Patients with psychiatric disorders
Pregnancy or breastfeeding
Presence of hematological disease
Patients with alcohol-drug addiction
Patients who use daily opioids for any reason

Sites / Locations

Burhan Dost

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group PIFB

Group TTMPB

Arm Description

PIF block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA

TTMP block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA

Outcomes

Primary Outcome Measures

Morphine consumption in the first 24 hours after surgery

Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.

Secondary Outcome Measures

Postoperative pain: NRS score

Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation.In addition, the time until first analgesic requirement will be recorded. The NRS is an 11-point numeric scale which ranges from 0 to 10.

Postoperative nausea and vomiting (PONV)

The patients will be verbally evaluated according to a descriptive five-point PONV scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

Patient satisfaction

Patients' satisfaction with pain management will be evaluated with a 5-point verbal satisfaction scale at the end of 24 hours. The Likert scale is 5 = very satisfied, 4 = satisfied, 3 = unsure, 2 = dissatisfied, 1 = very dissatisfied.

The number of patient required rescue analgesic

The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.

Time to extubation

After the operation, the time until the patient is extubated will be recorded.

Length of stay in the ICU

Total duration of stay in ICU will be recorded.

Length of stay in the hospital

Their stay in the hospital will be recorded.

The number of patients with complications

The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.

Full Information

NCT ID

NCT04791592

First Posted

March 9, 2021

Last Updated

April 22, 2021

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT04791592

Brief Title

Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery

Official Title

Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

March 12, 2021 (Actual)

Primary Completion Date

April 14, 2021 (Actual)

Study Completion Date

April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.

Detailed Description

It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries. The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy. Patients will be divided into two groups: Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours. Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Coronary Artery Disease

Keywords

Pain, Postoperative, Surgery, Cardiac, Nerve, Block

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patients will be randomly classified into two groups.

Masking

ParticipantInvestigator

Masking Description

Patients randomly will be classified into two groups using opaque sealed envelopes. Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group is placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group written in the envelope. An anesthesiologist with expertise in regional anesthesia will perform PIF and TTP block to ensure the block's quality and consistency.

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group PIFB

Arm Type

Active Comparator

Arm Description

PIF block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA

Arm Title

Group TTMPB

Arm Type

Active Comparator

Arm Description

TTMP block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA

Intervention Type

Procedure

Intervention Name(s)

Single-injection, ultrasound-guided bilateral PIF block.

Intervention Description

PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.

Intervention Type

Procedure

Intervention Name(s)

Single-injection, ultrasound-guided bilateral TTMP block.

Intervention Description

TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.

Primary Outcome Measure Information:

Title

Morphine consumption in the first 24 hours after surgery

Description

Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.

Time Frame

Postoperative day 1

Secondary Outcome Measure Information:

Title

Postoperative pain: NRS score

Description

Time Frame

Postoperative Day 1

Title

Postoperative nausea and vomiting (PONV)

Description

Time Frame

Postoperative Day 1

Title

Patient satisfaction

Description

Time Frame

Postoperative Day 1

Title

The number of patient required rescue analgesic

Description

The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.

Time Frame

Postoperative Day 1

Title

Time to extubation

Description

After the operation, the time until the patient is extubated will be recorded.

Time Frame

Postoperative Day 1

Title

Length of stay in the ICU

Description

Total duration of stay in ICU will be recorded.

Time Frame

The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days

Title

Length of stay in the hospital

Description

Their stay in the hospital will be recorded.

Time Frame

Measured in days admitted in the hospital, an average of 7 days

Title

The number of patients with complications

Description

The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.

Time Frame

Postoperative 7 days on an average

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery) BMI <35 kg / m2 Exclusion Criteria: Emergent surgeries, redo cases, minimally invasive procedures Patients who do not want to participate Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale) Hypersensitivity or history of allergies to local anesthetics Patients with severe major organ dysfunction (such as renal or hepatic insufficiency) LVEF <30 Patients with psychiatric disorders Pregnancy or breastfeeding Presence of hematological disease Patients with alcohol-drug addiction Patients who use daily opioids for any reason

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deniz Karakaya

Organizational Affiliation

Ondokuz Mayıs University

Official's Role

Study Director

Facility Information:

Facility Name

Burhan Dost

City

Samsun

ZIP/Postal Code

55270

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32798172

Citation

Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.

Results Reference

background

PubMed Identifier

32032103

Citation

Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.

Results Reference

background

PubMed Identifier

31356362

Citation

Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.

Results Reference

background

PubMed Identifier

31833864

Citation

Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.

Results Reference

background

PubMed Identifier

30412813

Citation

Markham T, Wegner R, Hernandez N, Lee JW, Choi W, Eltzschig HK, Zaki J. Assessment of a multimodal analgesia protocol to allow the implementation of enhanced recovery after cardiac surgery: Retrospective analysis of patient outcomes. J Clin Anesth. 2019 May;54:76-80. doi: 10.1016/j.jclinane.2018.10.035. Epub 2018 Nov 6.

Results Reference

background

PubMed Identifier

32665179

Citation

Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.

Results Reference

result

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Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery

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