Lidocaine Clinical Trial
Official title:
Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy?
Verified date | March 2018 |
Source | Louisiana State University Health Sciences Center in New Orleans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to determine if there is a clinically meaningful difference in pain perception for women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant. This will be a double blinded randomized control trial.
Status | Active, not recruiting |
Enrollment | 129 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - need for in office diagnostic flexible cystoscopy Exclusion Criteria: - urethral stricture - simultaneous scheduling or performed additional procedure - current urinary tract infection - hypersensitivity to local anesthetic of amide type |
Country | Name | City | State |
---|---|---|---|
United States | Louisiana State University- Health Science Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center in New Orleans |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain and satisfaction | Composite of pain and satisfaction as determined by a Numeric Rating Scale for pain (validated measure) rating pain, as well as answers to yes or no questions asking if patient would repeat procedure in same method and if pain medicine is needed at end of procedure. | Recorded immediately after the procedure | |
Secondary | Anticipated pain | Composite of pain anticipated during procedure and compared to actual pain perceived as determined by a Numeric Rating Scale for pain (validated measure) rating pain | Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure |
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