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

August 18, 2026 updated by: Kathryn Kurchena, Women and Infants Hospital of Rhode Island

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to 23% of women with chronic pelvic pain have a component of pelvic floor myofascial pain, described as hypertonic, tender pelvic floor muscles with sensitive trigger points. The mainstay of treatment for pelvic floor myofascial pain is pelvic floor physical therapy. However, some areas of hypertonicity may be refractory to physical therapy and require alternative treatment strategies such as steroids, nonsteroidal anti-inflammatory drugs, muscle relaxants, antidepressants, and TPI. TPI of a local anesthetic with or without steroids or botulinum toxin have shown improvement in pelvic pain associated with pelvic floor dysfunction. Transvaginal TPI are commonly performed for patients in the office, as well as in the operating room with sedation or general anesthesia. Acute pain with prior in-office TPI or fear of pain is a common reason that patients elect for TPI in the operating room, which is associated with higher healthcare cost and clinical risk.

There is growing interest in analgesic options with in-office gynecologic procedures. The American College of Obstetricians and Gynecologists released a Clinical Consensus outlining the urgent need for providers to have a better understanding of pain-management options and avoid underestimating patient pain during in-office procedures.

Topical anesthetics have been extensively studied in different populations for a range of needle procedures and more recently have been shown to be effective in reducing pain during minor gynecologic procedures. Lidocaine-prilocaine cream is a well-tolerated topical anesthetic, which has demonstrated safety in pediatric and geriatric populations. It is FDA-approved for use on genital mucus membranes.

This study is a single-institution, pilot, randomized, double-blinded, placebo-controlled trial comparing the efficacy of lidocaine-prilocaine cream with placebo for analgesia during office-based levator muscle trigger point injection in women with myofascial pelvic pain. Study Period: August, 2026 to July, 2028.

Key study personnel (KSP) at the Urogynecology and Reconstructive Pelvic Surgery Office will identify and enroll patients with myofascial pelvic pain undergoing trigger point injection at their procedural visit. Patients who agree to participate in the study will be consented via consent forms at their procedural visit. Patients will be randomized using block randomization to one of two groups: pre-procedural treatment with lidocaine-prilocaine cream or placebo cream. The lidocaine-prilocaine cream and the placebo cream are both unscented, the same color and texture. They will both be dispensed in identical packaging to ensure study personnel; Urogynecology attending and fellow physicians as well as the patient are blinded to the study assignment. KSP will bring the correct medication to the room for provider application.

Specifically, the provider will apply either 5 grams of 2.5% lidocaine-prilocaine cream or 5 grams of the placebo cream with a single, gloved digit to the posterior vaginal epithelium, along the planned distribution of TPI approximately 10 minutes prior to the procedure.

Participants will indicate the severity of their pelvic floor pain immediately prior to administration of the intervention medication using a 100 mm visual analog scale, during the procedure, and immediately post-procedure. The scales will be provided on paper for participants to complete and be marked with a unique patient identification number. The completed scales will be collected by KSP and stored confidentially.

Given that this is a medication intervention study, we have asked Dr. Nicole Korbly, Assistant Professor and Clinical Educator at the Warren Alpert Medical School of Brown University and Division of Urogynecology and Reconstructive Pelvic Surgery to serve as Data Safety Monitor. Every three to six months she will review the data, as well as any and all adverse events and ensure proper reporting to the Institutional Review Board.

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kathryn Kurchena, MD
Phone Number: 48767 401-274-1122
Email: KKurchena@wihri.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patients 18 years or older
Patients who are undergoing in-office levator muscle trigger point injection for myofascial pelvic pain
Able to give informed consent for the study

Exclusion Criteria:

Documented allergy to lidocaine or prilocaine
Use of lidocaine or prilocaine within last 72 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMLA (lidocaine-prilocaine) Cream	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.
Placebo Comparator: Placebo (compounding, inactive cream)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Procedural Pain score Time Frame: intra-procedure	Using a 100 mm visual analog scale (0 mm indicating no pain and 100 mm indicating severe and intolerable pain), the patients will be asked during the procedure to indicate their pain level. This will be considered their maximum perceived pain during the procedure itself.	intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Procedure Pain score Time Frame: 0 minutes post-procedure	Using a 100 mm visual analog scale (0 mm indicating no pain and 100 mm indicating severe and intolerable pain), the patients will be immediately post (0 minutes post procedure) to indicate their pain level. This will be considered their perceived pain immediately after the procedure.	0 minutes post-procedure
Patient satisfaction with analgesia Time Frame: 0 minutes post-procedure	Immediately post-procedure, patient will be asked, "How satisfied were you with your pain control during your trigger point injections?" The answer format will be a 5-point satisfaction scale as follows: very satisfied, satisfied, neither, dissatisfied, very dissatisfied.	0 minutes post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

STUDY00001191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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