ESP Block Versus Wound Infiltration for Laminectomy

Официальное название

ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial

Обзор

Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy

Вмешательства

• Препарат ESP block with saline
  Bilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra)
• Препарат Wound infiltration with saline
  Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
• Препарат ESP block with local anesthetic
  Bilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra)
• Препарат Wound infiltration with local anesthetic
  Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.

Первичные конечные точки

• Tramadol consumption [Срок оценки: Evaluated from extubation for the first post-operative 24 hours]

Вторичные конечные точки (11)

• Pain 0 hours [Срок оценки: At extubation]
• Pain 6 hours [Срок оценки: 6 hours after end of surgery]
• Pain 12 hours [Срок оценки: 12 hours after end of surgery]
• Pain 24 hours [Срок оценки: 24 hours after end of surgery]
• Time to first analgesic requirement [Срок оценки: 24 hours after end of surgery]
• Incidence of post operative nausea-vomiting [Срок оценки: 24 hours after end of surgery]
• Incidence of post operative respiratory depression [Срок оценки: 24 hours after end of surgery]
• Incidence of post operative pruritus [Срок оценки: 24 hours after end of surgery]
• Incidence of post operative motor block [Срок оценки: 24 hours after end of surgery]
• Intraoperative opioid consumption [Срок оценки: At extubation]
• Evaluation of patient satisfaction [Срок оценки: 24 hours after end of surgery]

Критерии участия

Критерии включения

-Planned 1 or 2 level surgical laminectomy

Критерии исключения

• Allergy to local anesthetics
• Refusal of consent
• Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
• Hemopathies that predispose to bleeding
• Gastrointestinal ulcer or bleeding
• Local infection
• Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• University Hospital of Padova — Padova

Идентификаторы

NCT: NCT05271331 · 5211/AO/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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