Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03390790
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2017-10-20
Brief Title:
Lidocaine for Pain After Urodynamic Testing
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urodynamic testing can be associated with mild discomfort particularly at the time of insertion repositioning and removal of the bladder catheter a tube inserted into the bladder via the urethra Few studies have investigated ways to improve patient comfort during this procedure In this study the investigators want to see if applying external lidocaine a numbing gel prior to the procedure can help to minimize patient discomfort
Detailed Description:
Urodynamic testing can be associated with mild discomfort particularly at the time of insertion repositioning and removal of the bladder catheter a tube inserted into the bladder via the urethra Few studies have investigated ways to improve patient comfort during this procedure In this study the investigators want to see if applying lidocaine a numbing gel prior to the procedure can help to minimize patient discomfort
Participation in this study will involve only 1 clinic visit for urodynamic testing plus 2 phone calls to ask participants about pain 1 at 4-6 hours after testing and 1 at 24 hours after testing Additionally the investigators will record any adverse effects such as an allergic reaction to the gel or new irritationpain that happen within 2 weeks after testing
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing The placebo gel will be a standard lubricant gel meaning that it contains no active drug The assigned study regimen will be chosen by chance like flipping a coin Participants will have an equal 5050 chance of being given either study regimen Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting Additionally a member of the study team will ask participants about their pain level before and after the testing The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study
Participation in this study will involve only 1 clinic visit for urodynamic testing plus 2 phone calls to ask participants about pain 1 at 4-6 hours after testing and 1 at 24 hours after testing Additionally the investigators will record any adverse effects such as an allergic reaction to the gel or new irritationpain that happen within 2 weeks after testing
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing The placebo gel will be a standard lubricant gel meaning that it contains no active drug The assigned study regimen will be chosen by chance like flipping a coin Participants will have an equal 5050 chance of being given either study regimen Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting Additionally a member of the study team will ask participants about their pain level before and after the testing The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None