M-TAPA Block for Analgesia After Open-Heart Surgery

NCT07232979 | Not Yet Recruiting

• 1 other identifier: Bursa City Hospital 002
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain following open-heart surgery is primarily caused by median sternotomy, although additional contributors include costovertebral joint stress related to sternal retraction and the presence of chest wall and mediastinal drains during the postoperative period. This pain is often severe, especially in the early postoperative hours, making effective management both challenging and essential. Insufficient pain control frequently necessitates high doses of opioids, which may lead to adverse effects such as nausea, vomiting, respiratory complications, and postoperative delirium. Excessive use of anesthetic agents or opioids can also delay extubation and prolong the process of weaning from mechanical ventilation. The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a regional anesthesia technique performed beneath the costal margin between the internal oblique and transversus abdominis muscles. It provides broad dermatomal coverage, extending approximately from the upper thoracic to the lower thoracic and upper lumbar segments. This study aims to evaluate the postoperative analgesic effectiveness of combining the M-TAPA block with a parasternal block in patients undergoing open-heart surgery.

Conditions

Postoperative Pain; Acute Pain

Keywords

M-TAPA block; Open-heart surgery; parasternal block; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  Fentanyl will be prepared at a concentration of 10 µg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 µg.

  0, 2, 4, 8, 16 and 24 hours

Secondary Outcomes (2)

• Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

  0, 2, 4, 8, 16 and 24 hours

• Global recovery scoring system (patient satisfaction scale)- QoR-15

  The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

Study Arms (2)

Group M-TAPA

ACTIVE COMPARATOR

The M-TAPA and parasternal blocks will be administered before surgery.

Other: M TAPA block; Other: Parasternal blocks

Group Control

ACTIVE COMPARATOR

Preoperatively, a parasternal block and local anesthetic infiltration at the chest tube insertion sites will be administered to all patients.

Other: Parasternal blocks; Other: Local infiltration

Interventions

M TAPA block OTHER

In the M-TAPA group, the block will be performed preoperatively with the patient in the supine position under ultrasound guidance using a high-frequency linear probe (GE ML6-15-D Matrix Linear, Boston, USA) and an 80-mm block needle (Stimuplex Ultra®, Braun, Melsungen, Germany). After identifying the appropriate plane between the transversus abdominis muscle and the lower surface of the costal cartilage, 5 mL of saline will be injected to confirm correct placement. Subsequently, 20 mL of 0.25% bupivacaine will be injected bilaterally (a total of 40 mL for both sides).

Group M-TAPA

Parasternal blocks OTHER

Before intubation, the block will be performed under aseptic conditions using a high-frequency ultrasound probe (GE ML6-15-D Matrix Linear, Boston, USA) placed immediately lateral to the sternum after identifying the second to fourth intercostal spaces. An 80-mm echogenic block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will then be advanced using an in-plane approach from the skin toward the plane between the pectoralis major and intercostal muscles. A total of 10 mL of 0.25% bupivacaine will be injected bilaterally.

Group Control; Group M-TAPA

Local infiltration OTHER

Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.

Group Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 85 years with ASA physical status II-III who are scheduled to undergo elective open-heart surgery will be included.

You may not qualify if:

• Patients who refuse to participate in the study
• Patients with coagulopathy
• Patients with a history of allergy or toxicity to local anesthetics
• Patients with hepatic or renal failure
• Patients with uncontrolled diabetes mellitus
• Patients with uncontrolled hypertension
• Mentally disabled patients
• Patients receiving chronic pain therapy (opioid use)
• Patients using antidepressant medications
• Patients with neuropathic pain
• Patients with infection at the injection site
• Pregnant, suspected pregnant, or breastfeeding women

Sponsors & Collaborators

• Bursa City Hospital: lead
• Emre ULUSOY: collaborator

Related Publications (1)

• Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.

  PMID: 36581838 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Eralp Çevikkalp

CONTACT

+905054554875; eralpcevikkalp@hotmail.com

Emre ULUSOY

CONTACT

+905379492799; emreulusoy36@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share