Myofacial PainPhase 4NCT07778043
Lidocaine-prilocaine Cream as Analgesia for In-office Levator Muscle Trigger Point Injections
A Phase 4 study testing Lidocaine-Prilocaine Cream 2.5-2.5% and Permeation-enhancing vanishing cream in people with Myofacial Pain and Pelvic Pain, run by Women and Infants Hospital of Rhode Island.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myofacial Pain, Pelvic Pain
- What is being tested?
- Lidocaine-Prilocaine Cream 2.5-2.5% and Permeation-enhancing vanishing cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to Jul 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Documented allergy to lidocaine or prilocaine
- Use of lidocaine or prilocaine within last 72 hours
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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, 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.
- Conditions
- Myofacial Pain, Pelvic Pain
- Being tested
- Lidocaine-Prilocaine Cream 2.5-2.5%, Permeation-enhancing vanishing cream
- Medical subject headings
- Facial Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Permeation-enhancing vanishing creamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EMLA (lidocaine-prilocaine) Cream | Experimental | Not described Receives: Drug: Lidocaine-Prilocaine Cream 2.5-2.5% |
| Placebo (compounding, inactive cream) | Placebo comparator | Not described Receives: Other: Permeation-enhancing vanishing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intra-procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: 0 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Kurchena, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778043
- Sponsor's protocol ID
- STUDY00001191
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Aggarwal K, Lamba AK, Faraz F, Tandon S, Makker K. Comparison of anxiety and pain perceived with conventional and computerized local anesthesia delivery systems for different stages of anesthesia delivery in maxillary and mandibular nerve blocks. J Dent Anesth Pain Med. 2018 Dec;18(6):367-373. doi: 10.17245/jdapm.2018.18.6.367. Epub 2018 Dec 28.
PubMed 30637347Wahlgren CF, Lillieborg S. Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients. Plast Reconstr Surg. 2001 Mar;107(3):750-6. doi: 10.1097/00006534-200103000-00015.
PubMed 11304601Jackson AA, Frisco SC, Lynch CM, Tanner JP, Propst K. Topical lidocaine for pessary removal and reinsertion pain reduction: a randomized clinical trial. Am J Obstet Gynecol. 2025 Mar;232(3):303.e1-303.e7. doi: 10.1016/j.ajog.2024.09.004. Epub 2024 Sep 10.
PubMed 39265711Taege SK, Adams W, Mueller ER, Brubaker L, Fitzgerald CM, Brincat C. Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.
PubMed 28594757Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.
PubMed 25445103Keskin AE, Onaran Y, Duvan IC, Simavli S, Kafali H. Topical anesthetic (lidocaine-prilocaine) cream application before speculum examination in postmenopausal women. J Minim Invasive Gynecol. 2012 May-Jun;19(3):350-5. doi: 10.1016/j.jmig.2012.01.005. Epub 2012 Mar 13.
PubMed 22417905Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.
PubMed 11889416Pain Management for In-Office Uterine and Cervical Procedures: ACOG Clinical Consensus No. 9. Obstet Gynecol. 2025 May 15;146(1):161-177. doi: 10.1097/AOG.0000000000005911.
PubMed 40373312Bartley J, Han E, Gupta P, Gaines N, Killinger KA, Boura JA, Farrah M, Gilleran J, Sirls LT, Peters KM. Transvaginal Trigger Point Injections Improve Pain Scores in Women with Pelvic Floor Hypertonicity and Pelvic Pain Conditions. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):392-396. doi: 10.1097/SPV.0000000000000581.
PubMed 29621041Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62. doi: 10.1002/nau.20393.
PubMed 17195176FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.
PubMed 22503015Pastore EA, Katzman WB. Recognizing myofascial pelvic pain in the female patient with chronic pelvic pain. J Obstet Gynecol Neonatal Nurs. 2012 Sep-Oct;41(5):680-91. doi: 10.1111/j.1552-6909.2012.01404.x. Epub 2012 Aug 3.
PubMed 22862153Ortiz DD. Chronic pelvic pain in women. Am Fam Physician. 2008 Jun 1;77(11):1535-42.
PubMed 18581833Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
PubMed 8598948