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Shoulder RA Survey Study (RA)

9 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

140

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital, University Health Network
        • Contatto:
        • Investigatore principale:
          • Ki Jinn Chin, MBBS, MD, FRCPC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To determine the proportion of patients who have a preference for nerve block with a continuous infusion versus a single injection of local anesthetic
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To determine predictive factors for catheter preference based on demographic characteristics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Health Network, Toronto

Investigatori

  • Investigatore principale: Ki Jinn Chin, MBBS MD FRCPC, University Health Network, Toronto

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 25-6110
  • CTO Project ID# 5621 (Altro identificatore: CTO (Clinical Trials Ontario))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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