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Local Anesthetic

lidocaine with epinephrine for Stress Incontinence

Phase 4
Recruiting
Research Sponsored by West Penn Allegheny Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7.
Awards & highlights

Study Summary

This trial is looking at ways to reduce postoperative urinary retention in women who undergo midurethral sling surgery for stress urinary incontinence. The surgery is effective but can lead to urinary retention in

Who is the study for?
This trial is for women aged 18 or older who can give consent and speak English. It's designed for those undergoing midurethral sling surgery to treat stress urinary incontinence, aiming to reduce postoperative urinary retention.Check my eligibility
What is being tested?
The study compares the effects of injecting normal saline with epinephrine versus lidocaine with epinephrine during surgery on the duration of postoperative urinary retention in patients receiving a midurethral sling.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, allergic reactions, and temporary numbness. The impact on post-surgery urinary function is also being studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7.
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be asked to mark their pain on a vas scale administered 2 hours and 6 hours following surgery. the subsequent assessments will be completed by patients with an at-home form through postoperative day #7. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of urinary retention
Secondary outcome measures
Postoperative pain: VAS scale
Other outcome measures
Patient satisfaction following surgery: Likert Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 0.5% lidocaine with epinephrineExperimental Treatment1 Intervention
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
Group II: Normal saline with epinephrineActive Control1 Intervention
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lidocaine with epinephrine
2017
N/A
~250

Find a Location

Who is running the clinical trial?

West Penn Allegheny Health SystemLead Sponsor
35 Previous Clinical Trials
5,859 Total Patients Enrolled
Lindsay Turner, MDStudy DirectorDepartment of Obstetrics and Gynecology, Allegheny Health Network
1 Previous Clinical Trials
154 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
Liposomal Bupivacaine Decreases Pain Following Retropubic Sling Placement: A Randomized Placebo-controlled Trial
Mazloomdoost, Donna, Rachel N. Pauls, Erin N. Hennen, Jennifer Y. Yeung, Benjamin C. Smith, Steven D. Kleeman, and Catrina C. Crisp. 2017. “Liposomal Bupivacaine Decreases Pain Following Retropubic Sling Placement: A Randomized Placebo-controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2017.07.001.
clinicaltrials.govStudy
The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling
Lindsay Turner 2019. "The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913845.
All > Urinary Incontinence
~37 spots leftby Dec 2025
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