Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651788
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Does Freeze Spray Work
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Freeze Spray Work Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions such as osteoarthritis tendinitis carpal tunnel syndrome trigger finger and de Quervains tenosynovitis While these injections have demonstrated effectiveness in alleviating symptoms the discomfort associated with the procedure can be a source of anxiety and apprehension for patients This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution
Detailed Description:
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions such as osteoarthritis tendinitis carpal tunnel syndrome trigger finger and de Quervains tenosynovitis While these injections have demonstrated effectiveness in alleviating symptoms the discomfort associated with the procedure can be a source of anxiety and apprehension for patients This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution
In response to this concern orthopaedic providers have turned to freeze sprays Ethyl chloride which are topical anesthetics that rapidly cool the skin and underlying tissues By numbing the injection site superficially freeze sprays offer the potential to mitigate patient discomfort during corticosteroid injections thus improving the overall patient experience and potentially enhancing treatment compliance
However despite the popularity of freeze spray usage in orthopaedics many orthopaedic providers have concerns about its efficacy when it comes to providing pain relief There still needs to be comprehensive scientific evidence evaluating its efficacy and safety A previous study evaluated the efficacy of freeze spray in hand surgery in a randomized study of 150 subjects without standardized outcomes measures These investigators showed no difference between those receiving freeze spray vs no spray in pain or anxiety another study of vapocoolant spray in IV start sites in the emergency department similarly showed no difference in pain or anxiety Based on the literature there is no definitive standard of care to use freeze spray with injections and this is the gap in knowledge we wish to answer with a rigorous placebo-controlled study This study will differ from the previous similar study in that the investigators will recruit double the number of patients and use standardized commonly accepted questionnaires The use of a questionnaire based on standardized metrics will provide a more comprehensive assessment of patient perceptions and satisfaction with the use of freeze spray Through a rigorous research approach the investigators aim to provide valuable insights into the impact of freeze spray on patient comfort injection success rates and any potential complications associated with its use
This study will contribute to the ongoing efforts of hand surgeons to refine their techniques minimize patient discomfort and optimize the delivery of corticosteroid injections Ultimately the investigators findings may have significant implications for the broader field of musculoskeletal medicine offering evidence-based guidance to improve the patient experience and outcomes in orthopaedic surgery
In response to this concern orthopaedic providers have turned to freeze sprays Ethyl chloride which are topical anesthetics that rapidly cool the skin and underlying tissues By numbing the injection site superficially freeze sprays offer the potential to mitigate patient discomfort during corticosteroid injections thus improving the overall patient experience and potentially enhancing treatment compliance
However despite the popularity of freeze spray usage in orthopaedics many orthopaedic providers have concerns about its efficacy when it comes to providing pain relief There still needs to be comprehensive scientific evidence evaluating its efficacy and safety A previous study evaluated the efficacy of freeze spray in hand surgery in a randomized study of 150 subjects without standardized outcomes measures These investigators showed no difference between those receiving freeze spray vs no spray in pain or anxiety another study of vapocoolant spray in IV start sites in the emergency department similarly showed no difference in pain or anxiety Based on the literature there is no definitive standard of care to use freeze spray with injections and this is the gap in knowledge we wish to answer with a rigorous placebo-controlled study This study will differ from the previous similar study in that the investigators will recruit double the number of patients and use standardized commonly accepted questionnaires The use of a questionnaire based on standardized metrics will provide a more comprehensive assessment of patient perceptions and satisfaction with the use of freeze spray Through a rigorous research approach the investigators aim to provide valuable insights into the impact of freeze spray on patient comfort injection success rates and any potential complications associated with its use
This study will contribute to the ongoing efforts of hand surgeons to refine their techniques minimize patient discomfort and optimize the delivery of corticosteroid injections Ultimately the investigators findings may have significant implications for the broader field of musculoskeletal medicine offering evidence-based guidance to improve the patient experience and outcomes in orthopaedic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None