Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery

Cardiac Disease Clinical Trial

Official title:

The Efficacy of Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285773
• Other study ID #: Medipol Hospital 36
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2024
• Est. completion date: November 10, 2024

Study information

• Verified date: February 2024
• Source: Medipol University
• Contact: Bahadir Ciftci, Assoc Prof, MD
• Phone: +905343736865
• Email: bciftci[@]medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.

Description:

Open heart surgery is defined as surgery performed on the heart valves, arteries, and other heart structures by cutting the sternum with a median sternotomy. Cardiovascular diseases are prevalent in the general global population and affect most of the older adult population. With the increase in life expectancy in recent years, there has been a significant increase in surgical procedures for cardiovascular diseases. ERAS recommends effective perioperative pain control to improve outcomes after Cardiac Surgery. Inadequate pain control after open heart surgery causes decreased mobilization, increased respiratory complications, prolonged hospital stays, and chronic pain. Post-heart surgery pain is most intense during the first two days and then decreases. Considering that 17% of patients report chronic pain after cardiac surgery, it is crucial to provide effective analgesia in the early postoperative period. Failure to adequately relieve post-operative pain may lead to increased pulmonary complications as a result of inability to breathe deeply, coughing due to fear of pain, and consequent inability to clear bronchial secretions. Moreover, increased endogenous catecholamines due to surgery and pain increase the heart's oxygen consumption by causing tachycardia and hypertension. This situation causes ischemia, heart failure, and arrhythmias in patients who have undergone cardiac surgery. In general, postoperative pain is reduced with opioids, which can cause various complications. Although the use of opioids is recommended in cardiac surgery due to their ischemic effects, multimodal perioperative pain management strategies are recommended in current anesthesia. The use of regional anesthesia as part of multimodal strategies is steadily increasing in cardiac surgeries performed through median sternotomy. Despite multimodal analgesia strategies using regional techniques, post-operative pain still emerges as an important problem in open heart surgery with median sternotomy. The leading causes of pain after cardiac surgery are; sternotomy incisions, chest retraction, dissection of the internal mammary artery, thoracic tubes, sternal wires, and visceral pain. Sternal pain is transmitted through intercostal nerves originating from T2-T6 spinal nerve roots, whereas various regional techniques are used for analgesia in parasternal region surgeries. Amongst these techniques, while parasternal blocks can be preferred as fascial plane blocks, these aim to block the anterior cutaneous branches of the T2-T6 thoracic nerves. Pectointercostal fascial block (PIFB) is an effective technique for controlling sternal pain in heart surgeries where median sternotomy is performed. In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 10, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification I-III
• Scheduled for cardiac surgery with elective median sternotomy under general anesthesia

Exclusion Criteria:

• a personal or family history of malignant hyperthermia,
• opioid sensitivity,
• alcohol or drug addiction,
• liver or kidney disease,
• skin infection in the area to be blocked,
• thoracic deformity,
• patients who are allergic to their medications,
• patients who do not agree to participate

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• RIFPB block
For RIFPB, a local anesthetic will be injected into the plane between the costal cartilage and the rectus abdominis muscle at the 6th-7th costal cartilage under US guidance. The in-plane technique will be used. After confirming the block location, 10 ml of 0.25% concentration marcaine (bupivacaine) will be used (bilateral).

Other:
• Postoperative analgesia management
Patients will be administered 10mg/kg paracetamol in the postoperative period every eight hours. If the NRS score is = 4, 1 mg kg-1 iv tramadol will be administered as a rescue analgesic.

Drug:
• PIFPB block
For PIFPB; the ultrasound probe for PIFB is placed 2-3 cm lateral to the upper third of the sternum, parallel to the sternum. A local anesthetic of 15 ml of 0.25% concentration of marcaine (bupivacaine) will be used between the pectoralis major and external intercostal muscles (bilateral).

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Elbardan IM, Shehab AS, Mabrouk IM. Comparison of Transversus Thoracis Muscle Plane Block and Pecto-Intercostal Fascial Plane Block for enhanced recovery after pediatric open-heart surgery. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101230. doi: 10.1016/j.accpm.2023.101230. Epub 2023 Apr 7. — 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

Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available. — View Citation

Zhang Y, Gong H, Zhan B, Chen S. Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2021 Jun 22;21(1):175. doi: 10.1186/s12871-021-01391-w. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global recovery scoring system / Quality of Recovery 15 questionairre	We will use the Turkish version of the Quality of Recovery / QoR-15 questionnaire. The QoR-15 ranges from 0-150 points. 0 points means the worst score, and 150 points means the best score. The QoR-15 has sections: Global QoR-15 Total: 150 (max) Physical Comfort 50 (max) Emotional State 40 (max) Psychological Support 20 (max) Physical Independence 20 (max) Pain 20 (max)	Change from baseline score at postoperative 24 hour
Secondary	Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")	Change from Baseline Pain Scores at Postoperative 24 hours.	Postoperative 24 hours period
Secondary	The use of rescue analgesia	Tramadol using (Number of Participants using)	Postoperative 24 hours period
Secondary	The use of rescue analgesia	Tramadol using (Concentration of tramodol)	Postoperative 24 hours period