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Идёт набор NCT07641842

Shoulder RA Survey Study

Наблюдательное Nerve Block

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Nerve Block. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Patient Experience of Benefits and Limitations of Single Injection Peripheral Nerve Block for Shoulder Surgery: A Cross-sectional Survey

Обзор

The purpose of this study, called a cross-sectional survey, is to interview patients on their experiences of pain and recovery following keyhole shoulder surgery, after receiving a single shot nerve block in addition to a general anesthetic. The researchers would like to explore patients' experiences to see if there are groups of patients who may benefit from insertion of a nerve catheter as compared to a single shot nerve block injection for keyhole shoulder surgery.

Подробное описание

At Toronto Western Hospital (TWH) and Women's College Hospital (WCH), Toronto, the standard anesthetic given to patients undergoing keyhole shoulder surgery is a single shot nerve block, followed by a general anesthetic. Shoulder surgery is known to be painful, and the main aim of the nerve block is to provide pain relief once you wake up after surgery. A nerve block involves using an ultrasound machine to help inject local anesthetic medicine around the nerves which supply the shoulder, and a single shot injection lasts for 12-24 hours after the operation.

Patients may experience 'rebound' pain once the nerve block wears off, which may be severe. There is evidence suggesting that prolonging the duration of pain relief offered by the nerve block by insertion of a nerve catheter may be helpful in reducing 'rebound' pain. A nerve catheter is a thin tube which delivers local anesthetic pain relief continuously around the nerve, it can prolong the duration of pain relief from 12-24 hours to 48-72 hours.

The purpose of this study, is to interview patients on their experiences of pain and recovery following keyhole shoulder surgery, after receiving a single shot nerve block in addition to a general anesthetic. The researchers would like to explore patients' experiences to see if there are groups of patients who may benefit from insertion of a nerve catheter as compared to a single shot nerve block injection for keyhole shoulder surgery.

The followings will be done as part of the study:

Before Surgery:

After the patients consent to participate in this study, the study team will collect information from their medical records and by interviewing them, which includes age; height; weight; sex; ASA (American Society of Anesthesiologists) classification; frailty; history of previous nerve blocks; history of depression/anxiety; history of chronic pain; medicine history.

Day of Surgery:

The participants will receive standard clinical care for their surgery. The research team will collect information about their surgery from their medical chart.

After Surgery:

(While the participants are in the hospital)

The research team will provide the participants as part of their discharge paperwork, a set of written standardized instructions regarding their post-surgical pain control regimen.

(After the participants leave hospital)

The research team will collect information about their health from their medical chart and by interviewing them over the phone.

Telephone Follow-Up

Once the participants return home, they will be contacted by telephone to participate in two telephone interviews. The first one will take place 48-72 hours after their surgery, and the second one will take place a week after their surgery. During the interviews, they will speak with a member of the research team. Each interview will be about a maximum of 10 minutes in length and will take place while they are at home. They will be asked to provide information about their experiences with pain and the quality of recovery after their shoulder surgery. Based on their experience with the single-injection nerve block, investigators will also inquire whether they would have preferred a continuous nerve block catheter infusion.

Первичные конечные точки

  • To determine the proportion of patients who have a preference for nerve block with a continuous infusion versus a single injection of local anesthetic [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (6)
  • To determine predictive factors for catheter preference based on demographic characteristics [Срок оценки: Through study completion, an average of 1 year]
  • To determine predictive factors for catheter preference based on type and duration of shoulder surgery [Срок оценки: Through study completion, an average of 1 year]
  • To determine predictive factors for catheter preference based on pre-operative anxiety defined by the PROMIS Anxiety Scale short form 8a [Срок оценки: Through study completion, an average of 1 year]
  • To determine predictive factors for catheter preference based on pre-operative frailty [Срок оценки: Through study completion, an average of 1 year]
  • To identify the incidence of rebound pain following single-injection PNB (Peripheral Nerve Block) [Срок оценки: Through study completion, an average of 1 year]
  • To explore the association between experience of rebound pain and patient preference for a continuous nerve catheter [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

Participants must meet all the following inclusion criteria to be eligible for the study:

  • Patients receiving a single-injection PNB for outpatient arthroscopic shoulder surgery at TWH and WCH
  • Age ≥18 years
  • Able to communicate in English

Критерии исключения

  • Cognitive impairment (inability to consent to participate in study)
  • Refusal to participate in study
  • Patients with primary block failure defined as those without a detectable sensory or motor block (determined by inability to abduct the arm and numbness or loss of sensation to pinprick over lateral shoulder/deltoid muscle, C5 dermatome)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Toronto Western Hospital, University Health Network — Toronto

Идентификаторы

NCT: NCT07641842 · 25-6110 · CTO Project ID# 5621

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗