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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Coronary Artery Disease
• Interventions: Procedure: Single-injection, ultrasound-guided bilateral TTMP block.; Procedure: Single-injection, ultrasound-guided bilateral PIF block.

• Registration Number: NCT04791592
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-10
• Study Start: 2021-03-12
• Status Verified: 2021-04
• Primary Completion: 2021-04-14
• Study Completion: 2021-04-22
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TTMPB	Single-injection, ultrasound-guided bilateral TTMP block.	TTMP block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA
Group PIFB	Single-injection, ultrasound-guided bilateral PIF block.	PIF block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA

Primary Outcome Measures

Name	Time	Method
Morphine consumption in the first 24 hours after surgery	Postoperative day 1	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

Name	Time	Method
Postoperative pain: NRS score	Postoperative Day 1	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.
Length of stay in the hospital	Measured in days admitted in the hospital, an average of 7 days	Their stay in the hospital will be recorded.
The number of patients with complications	Postoperative 7 days on an average	The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.
Postoperative nausea and vomiting (PONV)	Postoperative Day 1	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	Postoperative Day 1	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	Postoperative Day 1	The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.
Time to extubation	Postoperative Day 1	After the operation, the time until the patient is extubated will be recorded.
Length of stay in the ICU	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	Total duration of stay in ICU will be recorded.

Trial Locations

Locations (1)

Burhan Dost; 🇹🇷 Samsun, Turkey