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Shoulder RA Survey Study (RA)

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

140

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To determine the proportion of patients who have a preference for nerve block with a continuous infusion versus a single injection of local anesthetic
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To determine predictive factors for catheter preference based on demographic characteristics
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 25-6110
  • CTO Project ID# 5621 (Andere Kennung: CTO (Clinical Trials Ontario))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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