Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07778043
PHASE4

Lidocaine-prilocaine Cream as Analgesia for In-office Levator Muscle Trigger Point Injections

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

Summary

Levator muscle trigger point injections (TPI) are a commonly performed procedure in the office for treatment of pelvic pain related to pelvic floor muscles. The most common concern related to in-office TPI is pain. Currently, there is limited information about which medications could reduce pain during TPI. Pain control during in-office gynecologic procedures is a very important topic, and doctors are researching possible options for pain control during these procedures. Lidocaine-prilocaine cream is U.S Food and Drug Administration (FDA) approved for use on the genital area as pretreatment for procedures involving needles. The purpose of this study is to assess if vaginal lidocaine-prilocaine cream reduces pain with TPI compared to a placebo cream.

Official title: Lidocaine-prilocaine Cream as Analgesia for In-office Levator Muscle Trigger Point Injections: a Pilot Randomized, Double-blinded, Placebo-controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-08-17

Completion Date

2028-07

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

Lidocaine-Prilocaine Cream 2.5-2.5%

This is the intervention cream. If randomized to this arm, 5 grams will be applied along the planned distribution of TPI approximately 10 minutes prior to the procedure.

OTHER

Permeation-enhancing vanishing cream

This is the placebo cream. If randomized to this arm, 5 grams will be applied along the planned distribution of TPI approximately 10 minutes prior to the procedure.