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

NCT04791592 | Completed

• 1 other identifier: PIFB-TTPB19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Coronary Artery Disease

Keywords

Pain, Postoperative; Surgery, Cardiac; Nerve, Block

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative day 1

Secondary Outcomes (8)

• Postoperative pain: NRS score

  Postoperative Day 1

• Postoperative nausea and vomiting (PONV)

  Postoperative Day 1

• Patient satisfaction

  Postoperative Day 1

• The number of patient required rescue analgesic

  Postoperative Day 1

• Time to extubation

  Postoperative Day 1

Study Arms (2)

Group PIFB

ACTIVE COMPARATOR

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

Procedure: Single-injection, ultrasound-guided bilateral PIF block.

Group TTMPB

ACTIVE COMPARATOR

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

Procedure: Single-injection, ultrasound-guided bilateral TTMP block.

Interventions

Single-injection, ultrasound-guided bilateral PIF block. PROCEDURE

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.

Group PIFB

Single-injection, ultrasound-guided bilateral TTMP block. PROCEDURE

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.

Group TTMPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Burhan Dost

Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 32798172 BACKGROUND

• 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.

  PMID: 32032103 BACKGROUND

• 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.

  PMID: 31356362 BACKGROUND

• 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.

  PMID: 31833864 BACKGROUND

• 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.

  PMID: 30412813 BACKGROUND

• 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.

  PMID: 32665179 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Coronary Artery Disease; Bites and Stings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Deniz Karakaya

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The patients will be randomly classified into two groups.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 10, 2021
• Study Start: March 12, 2021
• Primary Completion: April 14, 2021
• Study Completion: April 22, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)