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NCT Number: NCT07232979

M-TAPA Block for Analgesia After Open-Heart Surgery

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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).

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.

Local infiltration

Other

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

Primary outcomes

  1. opioid consumption

    Time frame: 0, 2, 4, 8, 16 and 24 hours

    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.

Secondary outcomes

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

    Time frame: 0, 2, 4, 8, 16 and 24 hours

    Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.

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

    Time frame: 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.

    Researchers will use the Turkish version of the Quality Improvement Survey/QoR-15. PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours. (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

Study contacts

Contact information is provided by the study sponsor or research team.

Emre ULUSOY

CONTACT

[email protected]

+905379492799

Eralp Çevikkalp

CONTACT

[email protected]

+905054554875

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Collaborators

  • Ulusoy, Emre, M.D.

Registry information

Official study title

The Effectiveness of the Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Analgesia and Recovery in Open-Heart Surgery: A Prospective, Double-Blind, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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