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Идёт набор NCT07746323

Effect of Modified Arm Positioning on Shoulder Pain After Thoracoscopic Lobectomy

Без фазы С лечением Ipsilateral Shoulder Pain Lung Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Modified Double-Arm Wrap Positioning, Traditional Arm-Board Position.
Кому может быть актуально
Состояния в реестре: Ipsilateral Shoulder Pain, Lung Neoplasms. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Modified Bilateral Arm Wrapping Position on Postoperative Ipsilateral Shoulder Pain in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy: A Prospective Randomized Controlled Trial

Обзор

This study is a prospective randomized controlled trial aiming to reduce shoulder pain after lung surgery. Shoulder pain on the surgical side is common after video-assisted thoracoscopic lobectomy, affecting about 20%-58% of patients. It can limit coughing, moving, and sleeping, and may delay recovery. The pain may come from two sources: nerve stimulation during surgery and the prolonged arm position used during the operation. While nerve stimulation is hard to avoid, the arm position can be modified. Currently, most pain treatments rely on medications or nerve blocks given after surgery, which have side effects or risks. No one has tried to prevent the pain by changing the arm position during the operation. We plan to enroll 270 patients scheduled for thoracoscopic lung removal surgery at Chengdu Shangjin Nanfu Hospital. Patients will be randomly divided into two groups. One group will receive the standard side-lying position with arms extended on arm boards (traditional position). The other group will receive a modified position where both arms are bent at the elbows and wrapped with surgical drapes, without using arm boards (modified double-arm wrap position). Our main goal is to compare the rate of shoulder pain (on the operated side) within 24 hours after surgery between the two groups. We will also compare pain on the opposite shoulder, pain severity, time needed to set up the position, total surgery time, hospital stay, and any nerve or skin complications. This study has been approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University. All participants will provide written informed consent. The findings may help improve intraoperative positioning and enhance early recovery after lung surgery.

Вмешательства

  • Другое Modified Double-Arm Wrap Positioning
    Participants in this arm are placed in the standard lateral decubitus position with a thin pillow under the lower side. Both upper arms are abducted to slightly less than 90 degrees, with elbows flexed at 90 degrees. A soft pad is placed between the hands. The forearms are positioned forward above the head, and both arms are wrapped together with surgical drapes for secure fixation. No arm boards are used. This modified position is maintained throughout the entire surgical procedure.
  • Другое Traditional Arm-Board Position
    Participants in this arm are placed in the standard lateral decubitus position with a thin pillow under the lower side. The contralateral upper arm is abducted to slightly less than 90 degrees with the elbow extended, and the forearm is placed on an arm board with a strap secured at the elbow. The ipsilateral arm is similarly positioned on a separate arm board. Both arm boards are used for fixation throughout the entire surgical procedure.

Первичные конечные точки

  • Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively [Срок оценки: Within the first 24 hours after surgery]
Вторичные конечные точки (8)
  • Incidence of Contralateral Shoulder Pain Within 24 Hours Postoperatively [Срок оценки: Within the first 24 hours after surgery (Postoperative Day 1, 0-24 hours)]
  • VAS scores for Ipsilateral Shoulder Pain at rest and on movement at 24 h postoperatively. [Срок оценки: At 24 hours postoperatively]
  • incidence of ipsilateral shoulder pain at postoperative day 3 [Срок оценки: Postoperative Day 3]
  • Positioning Setup Time [Срок оценки: Intraoperative recording]
  • Total Surgical Duration [Срок оценки: Intraoperative recording]
  • Postoperative Hospital Stay [Срок оценки: At hospital discharge]
  • Incidence of Brachial Plexus Injury-Related Signs Within 72 Hours Postoperatively [Срок оценки: Within 72 hours postoperatively]
  • Position-related pressure injury within 72 h [Срок оценки: From the end of surgery to 72 hours postoperatively]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • Diagnosed with pulmonary space-occupying lesion and scheduled for elective video-assisted thoracoscopic standard lobectomy.
  • ASA physical status classification I-III.
  • No pre-existing shoulder pain or shoulder mobility impairment prior to surgery.
  • No long-term use of analgesic medications (>1 week) before surgery.
  • Willing and able to provide written informed consent.

Критерии исключения

  • Severe cervical spine disease or history of brachial plexus injury.
  • Cognitive impairment or psychiatric disorder precluding understanding of pain assessment scales.

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

Китай · 1 центр
  • Chengdu Shangjin Nanfu Hospita — Чэнду

Идентификаторы

NCT: NCT07746323 · 2025(693)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗