Erector Spinae Block vs. Placebo Block Study

Официальное название

Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial

Обзор

Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.

Подробное описание

The ultrasound-guided erector spinae plane (ESP) block has been recently described for the successful management of thoracic neuropathic pain. The erector spinae muscle is formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deep to the erector spinae muscle, at the tip of the transverse process of the vertebra. Indirect access to the paravertebral space is gained providing analgesia without the risk of needle injury to structures in close proximity. Cadaveric studies have shown both ventral and dorsal rami of thoracic spinal nerves are affected when local anaesthetic is injected deep to the erector spinae muscle. The erector spinae muscle extends along the thoracolumbar spine allowing extensive cranio-caudal spread. The ventral ramus (intercostal nerve) is divided into the anterior and lateral branches. Its terminal branches provide the sensory innervation of the entire anterolateral wall. The dorsal ramus is divided into 2 terminal branches and it gives the sensory innervation to the posterior wall. Anterior spread of the local anaesthetic to the paravertebral space through the costotransverse foramina and the intertransverse complex provides both visceral and somatic analgesia.

While recent evidence supports statistically significant reductions in pain and opioid consumption among patients who receive an ESP block compared to systemic analgesia alone, the clinical significance of these differences are questionable the effect of ESP block on the patients' quality of recovery following ambulatory breast cancer surgery remains unclear.

Therefore, our objective is to determine whether or not the addition of an ESP block provides both superior analgesia and quality of recovery in patients undergoing ambulatory breast cancer surgery compared to systemic analgesia alone. We hypothesis that patients who received a preoperative ESP block will afford superior postoperative analgesia and improve the quality of recovery over the first 24 hours following surgery compared to those who receive a sham block for their ambulatory breast cancer surgery.

Вмешательства

• Процедура Erector spinae plane block
  80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.
• Процедура Placebo Block
  Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block under ultrasound guidance to stimulate a real block procedure.

Первичные конечные точки

• Acute postoperative pain at rest [Срок оценки: 24 hours postoperatively]
• Quality of postoperative recovery (QoR 15) [Срок оценки: 24 hours post-surgery]

Вторичные конечные точки (7)

• Postoperative pain scores [Срок оценки: 0, 6, 12, 18, 24 and 48 hours post-operatively]
• Intraoperative opioid consumption [Срок оценки: During the procedure]
• Postoperative opioid consumption [Срок оценки: 12,24,48 hours, 7 days postoperative]
• Duration of phase I (PACU) and phase II (surgical day care, SDC) stay [Срок оценки: From end of surgical procedure to 24 hours after surgery]
• Opioid-related side effects [Срок оценки: End of surgical procedure to 48 hours after surgery]
• Persistent post surgical pain DN4 screening tool [Срок оценки: 3 months post operatively]
• Block-related complications [Срок оценки: End of surgical procedure to 48 hours after surgery]

Критерии участия

Критерии включения

• ASA classification: I-III
• BMI < 35 kg/m2
• Day surgery procedure

Критерии исключения

• Prior ipsilateral breast surgery, excluding lumpectomy
• Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
• Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
• Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
• Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
• Patient refusal
• Chronic pain disorder
• Chronic opioid use (≥30 mg oxycodone / day)
• Contraindication (or allergy) to a component of multi-modal analgesia protocol
• Allergy to amide local anaesthetics used in nerve blocks
• Contraindications to any of the components of the standardized general anaesthesia
• Significant psychiatric disorder that would preclude objective study assessment
• Pregnancy/ women with nursing infants
• Unable to provide informed consent
• Unable to speak and read English

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Women's College Hospital — Toronto

Идентификаторы

NCT: NCT03978780 · 2021-0048-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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