A Phase 4 interventional study of Lidocaine-Prilocaine Cream 2.5-2.5% and Permeation-enhancing vanishing cream in Myofacial Pain and Pelvic Pain, sponsored by Women and Infants Hospital of Rhode Island. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Women and Infants Hospital of Rhode Island · Phase 4, Interventional, and Supportive care
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.
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, the investigators 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.
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 132 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lidocaine-Prilocaine Cream 2.5-2.5%
Other: Permeation-enhancing vanishing cream
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.
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.
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.
Time frame: intra-procedure
Post-Procedure 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 immediately post (0 minutes post procedure) to indicate their pain level. This will be considered their perceived pain immediately after the procedure.
Time frame: 0 minutes post-procedure
Patient satisfaction with analgesia
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.
Time frame: 0 minutes post-procedure
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.
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Women and Infants Hospital of Rhode Island