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Shoulder RA Survey Study (RA)

9. června 2026 aktualizováno: University Health Network, Toronto

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

140

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Ontario
      • Toronto, Ontario, Kanada, M5T 2S8
        • Toronto Western Hospital, University Health Network
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ki Jinn Chin, MBBS, MD, FRCPC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Patients scheduled for for an arthroscopic shoulder surgery at Toronto Western Hospital and Women's College Hospital, Toronto.

Popis

Inclusion Criteria:

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

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

Exclusion Criteria:

  1. Cognitive impairment (inability to consent to participate in study)
  2. Refusal to participate in study
  3. 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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To determine the proportion of patients who have a preference for nerve block with a continuous infusion versus a single injection of local anesthetic
Časové okno: Through study completion, an average of 1 year
To determine the proportion of patients undergoing outpatient arthroscopic shoulder surgery who have a preference for prolongation of their peripheral nerve block with a continuous infusion versus a single injection of local anesthetic
Through study completion, an average of 1 year

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To determine predictive factors for catheter preference based on demographic characteristics
Časové okno: Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on demographic characteristics
Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on type and duration of shoulder surgery
Časové okno: Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on type and duration of shoulder surgery
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
Časové okno: Through study completion, an average of 1 year
PROMIS Anxiety Scale measures self-reported anxiety traits based on 8 questions. Each question are rated on a 5-point scale (1-5) to get a total score between 5-40
Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on pre-operative frailty
Časové okno: Through study completion, an average of 1 year
Frail scale evaluates five areas assigning 1 point for each if present and zero if absent. Total score 0-5. Robust=0; Pre-frail=1-2 and Frail=3-5
Through study completion, an average of 1 year
To identify the incidence of rebound pain following single-injection PNB (Peripheral Nerve Block)
Časové okno: Through study completion, an average of 1 year
To identify the incidence of rebound pain following single-injection PNB measured in percentage
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
Časové okno: Through study completion, an average of 1 year
This association will be measured in only those participants that experienced rebound pain. This will be measured by calculating the number of patients that expressed a preference for continuous nerve catheter among those participants that experienced rebound pain and will be expressed as a percentage.
Through study completion, an average of 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ki Jinn Chin, MBBS MD FRCPC, University Health Network, Toronto

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2026

Termíny zápisu do studia

První předloženo

7. května 2026

První předloženo, které splnilo kritéria kontroly kvality

9. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. června 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 25-6110
  • CTO Project ID# 5621 (Jiný identifikátor: CTO (Clinical Trials Ontario))

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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