- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07641842
Shoulder RA Survey Study (RA)
Patient Experience of Benefits and Limitations of Single Injection Peripheral Nerve Block for Shoulder Surgery: A Cross-sectional Survey
Přehled studie
Postavení
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
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jayanta Chowdhury
- Telefonní číslo: 2016 4166035800
- E-mail: jayanta.chowdhury@uhn.ca
Studijní záloha kontaktů
- Jméno: Ki Jinn Chin, MBBS MD FRCPC
- E-mail: KiJinn.Chin@uhn.ca
Studijní místa
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Ontario
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Toronto, Ontario, Kanada, M5T 2S8
- Toronto Western Hospital, University Health Network
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Kontakt:
- Jayanta Chowdhury
- Telefonní číslo: 2016 4166035800
- E-mail: jayanta.chowdhury@uhn.ca
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Vrchní vyšetřovatel:
- Ki Jinn Chin, MBBS, MD, FRCPC
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Studijní plán
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
|
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To determine predictive factors for catheter preference based on pre-operative frailty
Časové okno: Through study completion, an average of 1 year
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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
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Through study completion, an average of 1 year
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To identify the incidence of rebound pain following single-injection PNB (Peripheral Nerve Block)
Časové okno: Through study completion, an average of 1 year
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To identify the incidence of rebound pain following single-injection PNB measured in percentage
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Through study completion, an average of 1 year
|
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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.
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Through study completion, an average of 1 year
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Ki Jinn Chin, MBBS MD FRCPC, University Health Network, Toronto
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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
Studuje produkt zařízení regulovaný americkým úřadem FDA
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