MedTrace Logo

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

NCT07778043 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Myofacial Pain
  • Pelvic Pain

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.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778043 on ClinicalTrials.gov