A Phase 4 interventional study of lidocaine gel and Lubricant Gel in Cystoscopy, Lidocaine and Pain Perception, sponsored by Louisiana State University Health Sciences Center in New Orleans. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 4, Interventional, and Treatment
Among 204 studies testing lidocaine in Pain — 19 open to participants now, 19 under way, 1 of them phase 3. Lidocaine · Pain.
Among the 204 studies testing lidocaine in Pain, this one is the 49th largest by enrollment of the 203 interventional ones, is one of 13 that started in 2016, is one of 63 in phase 4, and was the 131st registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 129 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →19 of the 204 studies testing lidocaine in Pain are open now, in 9 countries. Each count lists the studies.
Lidocaine: first FDA approval 1948 (XYLOCAINE), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years to 99 Years · female · healthy volunteers too.
The full table on the hub →204 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 13 started in 2016.
Median enrollment 66 across the 203 interventional studies. Of the 157 that completed or were terminated, 66 (42%) have results posted.
12 of 204 have an industry lead sponsor. The 10 most frequent:
Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Louisiana State University Health Sciences Center in New Orleans has 2 studies filed under Pain — fewer than ten, so there is no comparison to draw.
5 of the studies testing lidocaine in Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07785674Mayo ClinicArm Elevation for Prevention of Propofol Injection Pain | 2027-01 |
| NCT07883473Shaheed Zulfiqar Ali Bhutto Medical UniversityPudendal Nerve Block for Pain Relief During Episiotomy Repair | 2027-01-31 |
| NCT07889687Northwell HealthThis Study is Comparing Pain Outcomes After Urethral Bulking When Participants Are Randomized to Two Different Pain Medication Regimens. | 2027-04 |
| NCT07546370Monakshi SawhneyThe Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion | 2027-04-14 |
| NCT07048769Montefiore Medical CenterParacervical Block for Pain Reduction in Saline Infusion Sonograms | 2027-07 |
Among the 204 studies testing lidocaine in Pain, from their registry updates:
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.
The use of anesthetic lubricant during in-office flexible cystoscopy has been well studied men. Pain during cystoscopy can lead to poor compliance and follow-up. Very few studies challenging the use of anesthetic lubricant during cystoscopy have included women. Those that have, only recruited a small number with insignificant findings. A meta-analysis reviewed four studies looking at the efficacy of lidocaine gel on pain relief during flexible cystoscopy in men. Four hundred and eleven men underwent flexible cystoscopy with and without the use of lidocaine gel and those who received anesthetic gel were 1.7 times more likely not to experience moderate to severe pain than those who received placebo. The anatomy of the female and male urogenital tract differ. The female urethra is approximately 3cm in length while the male urethra averages 7 cm with an external and prostatic sphincter which is the location where the most discomfort is thought to occur. A randomized control trial of 144 women undergoing rigid cystoscopy and found that pain was decreased with lidocaine vs placebo, however other studies such found no difference in pain perception. The efficacy of lidocaine gel in women during flexible cystoscopy has not been studied. The use of lidocaine gel during diagnostic flexible cystoscopy in women is based on surgeon preference and experience, and use of either plain or anesthetic gel, is currently acceptable clinical practice. The morbidity and cost of local anesthesia associated with cystoscopy in women is unknown due to the lack of studies. The objective of this study is to determine if there is a clinically meaningful difference in pain perception in women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: lidocaine gel
Drug: Lubricant Gel
2% lidocaine jelly, injected into the urethra
Lubricating gel
Also known as: Plain gel
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.
Time frame: Recorded immediately after the procedure
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
Time frame: Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Louisiana State University Health Sciences Center in New Orleans