Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8, Canada
NCT Number: NCT07641842
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Toronto, Ontario, M5T 2S8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all the following inclusion criteria to be eligible for the study:
Exclusion criteria
Time frame: 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
Time frame: Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on demographic characteristics
Time frame: Through study completion, an average of 1 year
To determine predictive factors for catheter preference based on type and duration of shoulder surgery
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
To identify the incidence of rebound pain following single-injection PNB measured in percentage
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Patient Experience of Benefits and Limitations of Single Injection Peripheral Nerve Block for Shoulder Surgery: A Cross-sectional Survey
Acronym: RA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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