Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy

Официальное название

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial

Обзор

After laparoscopic cholecystectomy, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary eighth or ninth intercostal level with the patient kept supine after induction of anesthesia. Rather than puncturing the classical paraspinal target near the transverse process with a specific prone or lateral position of the patient, r-PVB is designed to exploit medial spread of local anesthetic along the intercostal-endothoracic-extrapleural continuum, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and specific body positioning. r-PVB addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.

Вмешательства

• Процедура Revised-Paravertebral Nerve Block
  Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery. Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.

Первичные конечные точки

• Mean postoperative NRS pain score during the first 2 postoperative days [Срок оценки: From discharge from the post-anesthesia care unit through postoperative day 2.]
• Mean QoR-15 score on postoperative days 1 and 2 [Срок оценки: Postoperative day 1 and postoperative day 2]

Вторичные конечные точки (6)

• Resting and movement NRS pain scores on postoperative days 1 and 2 [Срок оценки: Postoperative day 1 and postoperative day 2]
• Proportion of participants with NRS pain score 4 or greater [Срок оценки: Postoperative day 1 and postoperative day 2]
• Postoperative opioid and analgesic consumption [Срок оценки: Postoperative day 1 and postoperative day 2]
• Postoperative complications [Срок оценки: From surgery through postoperative day 30]
• Length of postoperative hospital stay [Срок оценки: From surgery through postoperative day 30]
• Patient satisfaction with analgesia [Срок оценки: Postoperative day 2]

Критерии участия

Критерии включения

• Age 18 years or older
• Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease

Критерии исключения

• Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
• Surgeon-estimated high likelihood of conversion to open surgery
• Chronic opioid use
• Heart failure, liver failure, or renal failure
• Coagulation disorders
• History of allergy to local anesthetics
• Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07566819 · E2026080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗