ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Обзор

Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures. The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs

Вмешательства

• Процедура Pre-operative Erector Spinae Plane block prior to DIEP surgery
  After obtaining informed consent to participate in the study, patients will be randomized by a computer 50/50 to either the Erector Spinae Plane group or the Transversus Abdominus Plane group at the time of their surgical clinic visit prior to their scheduled surgery. Then on the morning of surgery, the Erector Spinae Plane group will receive a bilateral ultrasound-guided Erector Spinae Plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected below the fascia of
• Процедура Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery
  On the morning of surgery, the patients in the TAPs group will receive a bilateral ultrasound-guided Transversus Abdominus plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle.

Первичные конечные точки

• Numerical Rating Scale [Срок оценки: 24 hours post injection]
• Mean Morphine Equivalents [Срок оценки: 24 hours post injection]

Вторичные конечные точки (7)

• Numerical Rating Scale [Срок оценки: 12 hours post injection]
• Michigan Body Map [Срок оценки: 24 hours post injection]
• Mean Morphine Equivalents [Срок оценки: 48 hours post injection]
• Numerical Rating Scale [Срок оценки: 48 hours post injection]
• Numerical Rating Scale [Срок оценки: 1 week post-operation]
• Numerical Rating Scale [Срок оценки: 2 weeks post-operation]
• Numerical Rating Scale [Срок оценки: 6 weeks post-operation]

Критерии участия

Критерии включения

• Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery

Критерии исключения

• Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT06091241 · STUDY00150240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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