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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791592
• Other study ID #: PIFB-TTPB19
• Status: Completed
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: April 22, 2021

Study information

• Verified date: April 2021
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 22, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Turkey	Burhan Dost	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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 Stud — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 Day 1
Secondary	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.	Postoperative Day 1
Secondary	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.	Postoperative Day 1
Secondary	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.	Postoperative Day 1
Secondary	Time to extubation	After the operation, the time until the patient is extubated will be recorded.	Postoperative Day 1
Secondary	Length of stay in the ICU	Total duration of stay in ICU will be recorded.	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
Secondary	Length of stay in the hospital	Their stay in the hospital will be recorded.	Measured in days admitted in the hospital, an average of 7 days
Secondary	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.	Postoperative 7 days on an average