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

NCT07778043 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00001191
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maximum Procedural Pain score

  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 Outcomes (2)

• Post-Procedure Pain score

  0 minutes post-procedure

• Patient satisfaction with analgesia

  0 minutes post-procedure

Study Arms (2)

EMLA (lidocaine-prilocaine) Cream

EXPERIMENTAL

Drug: Lidocaine-Prilocaine Cream 2.5-2.5%

Placebo (compounding, inactive cream)

PLACEBO COMPARATOR

Other: Permeation-enhancing vanishing cream

Interventions

Lidocaine-Prilocaine Cream 2.5-2.5% DRUG

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.

EMLA (lidocaine-prilocaine) Cream

Permeation-enhancing vanishing cream OTHER

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.

Placebo (compounding, inactive cream)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Related Publications (14)

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  PMID: 25445103 BACKGROUND

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  PMID: 40373312 BACKGROUND

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MeSH Terms

Conditions

Facial Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kathryn Kurchena, MD

CONTACT

401-274-1122; KKurchena@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecology and Reconstructive Pelvic Surgery Fellow

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 21, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08