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临床试验/NCT07232979
NCT07232979尚未招募不适用

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

Bursa City Hospital0 个研究点目标入组 80 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
opioid consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

opioid consumption

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

eralp çevikkalp

assoc prof

Bursa City Hospital

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