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2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy

11 augustus 2026 bijgewerkt door: Mara Sobel, Mount Sinai Hospital, Canada

A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%/Prilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy

The aim of this study is to determine if 5g of self-administered topical 2.5% lidocaine/2.5% prilocaine cream, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). Participants will be asked to self-administer the pre-filled vaginal applicator at least 10-15 minutes prior to the procedure. The patient will be asked to rate their pain throughout various steps of the procedure and complete a post-procedure survey afterwards. The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The proposed study is a double-blind, placebo-controlled randomized controlled trial (RCT). Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure and post-procedure survey will occur during the same visit.

Two separate randomization schedules will be generated, one for IUD insertion and one for endometrial biopsy, using computer-generated sequences prepared by an independent study coordinator. Randomization will occur via consecutively numbered, opaque, sealed envelopes containing the allocation code. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). The research coordinator (who is not involved in direct patient care) will open the allocation envelopes without the presence of the participant or the provider. They will prepare the self-applicators with either 5g of 2.5% lidocaine/2.5% prilocaine cream or 5g of placebo cream to maintain blinding. The patient will be instructed how to self-administer the applicator and dispense all 5g of cream into their vagina in the washroom. A patient education sheet highlighting instructions will also be provided. The patient will wait 10-15 mins and then will be brought into a room for the procedure. Once the procedure begins, pain scores at key intervals will be patient-reported by a 10-point numeric rating scale (NRS) and recorded by a research assistant. A global pain score using a 100mm visual analogue scale (VAS) at 5-minutes following the procedure will also be collected. Post-procedure, there will be a provider-completed questionnaire and a patient satisfaction questionnaire. The provider questionnaire will help describe details of the procedure and complications. The patient satisfaction questionnaire will describe feasibility, acceptability and satisfaction with self-administered cream. The primary outcome will be global pain score at 5-minutes post-procedure, which will be patient-reported by the 100 mm VAS. Secondary outcomes include: pain at specific pain points using a 10-point NRA (baseline after insertion of cream, after insertion of speculum, tenaculum placement, sounding of uterus (IUD only), IUD insertion or endometrial biopsy, and 1-minute post-procedure). Other secondary outcomes include pre- and post-procedure anxiety, procedural characteristics (uterine size, position, IUD type, number of biopsy passes), immediate complication and side effects, procedural difficulty, length of time to complete the procedure, and patient reported feasibility, acceptability, perceived control over pain and satisfaction.

Studietype

Ingrijpend

Inschrijving (Geschat)

174

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1Z5
        • Ontario Power Generation Building
        • Contact:
        • Hoofdonderzoeker:
          • Mara Sobel, MD
        • Onderonderzoeker:
          • Praniya Elangainesan, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
  • English speaking participants only

Exclusion Criteria:

  • Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
  • Misoprostol administration within 24 hours
  • Confirmed pregnancy
  • Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
  • Allergy to lidocaine, prilocaine or any other "-caine" type anesthetics or any of the non-medicinal ingredients found in the product
  • Patients with congenital or idiopathic methemoglobinemia
  • Patients with glucose-6-phosphate dehydrogenase deficiency
  • Severe kidney or liver disease
  • Previous history of local anesthetic systemic toxicity (LAST)
  • Baseline vital signs of systolic blood pressure <100, diastolic blood pressure <60 and/or pulse <60.
  • Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)
  • Active atopic dermatitis or skin involving vulva, vagina and/or cervix.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Medicated cream
5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator
Geneesmiddel: 2.5% lidocaine/2.5% prilocaine topical cream
5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator
Placebo-vergelijker: Placebo cream
5g of placebo VersaPro topical cream administered with vaginal self-applicator
Ander: VersaPro Cream Base for Compounding
5g of VersaPro cream administered by participant by vaginal self-applicator

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Global pain score
Tijdsspanne: Completed by patient 5-minutes post procedure.
Patient-reported pain measured using the 100-mm Visual Analogue Scale (VAS) 5 minutes following the procedure (endometrial biopsy or IUD insertion). The VAS ranges from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain (a worse outcome).
Completed by patient 5-minutes post procedure.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain scores at specific pain points during procedure
Tijdsspanne: During the procedure
Pain scores at specific pain points: baseline after insertion of cream, after insertion of the speculum, removal of excess cream with gauze, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure, which will be patient-reported verbally during the procedure on a scale from 0 (i.e. no pain) to 10 (worst pain imaginable). When more than one biopsy pass is required, only pain after the first pass will be recorded.
During the procedure
Anxiety levels
Tijdsspanne: After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
Patient-reported anxiety before and after the procedure, measured using a 5-point Likert scale ranging from 1 (very anxious) to 5 (very calm). Higher scores indicate less anxiety (a better outcome).
After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
Immediate complications of endometrial biopsy and/or IUD insertion
Tijdsspanne: Completed by the provider immediately after the procedure (within 30 mins post procedure).
Provider-reported immediate complications associated with the endometrial biopsy and/or IUD insertion, including difficulty of procedure, vasovagal reaction, vital sign changes, or other procedure-related complications. This will be assessed by the presence or absence of specific procedure-related complications.
Completed by the provider immediately after the procedure (within 30 mins post procedure).
Difficulty of procedure
Tijdsspanne: Completed by the provider immediately after the procedure (within 30 mins post procedure).
The difficulty of the procedure will be assessed with a Likert scale from 1 (least difficult) to 5 (most difficulty), provider reported.
Completed by the provider immediately after the procedure (within 30 mins post procedure).
Length of time for procedure completion
Tijdsspanne: During the procedure
Time will be recorded via stopwatch
During the procedure
Patient-reported acceptability, feasibility, and satisfaction with vaginal cream self-administration
Tijdsspanne: Completed by the patient immediately after the procedure (within 30 mins post procedure).

Patient-reported acceptability and satisfaction with self-administration will be assessed using a study-specific questionnaire evaluating ease and comfort of self-administration, perceived control, satisfaction with pain control and the self-application process, and willingness to use self-administration for a future gynecologic procedure.

Ease of administration, comfort with self-administration, satisfaction with pain control, satisfaction with the self-application process, and likelihood of choosing self-administration again will each be assessed using 5-point Likert scales ranging from 1 to 5, with higher scores indicating greater ease, comfort, satisfaction, or likelihood of future use (a better outcome). Additional acceptability measures, including confidence in correct application, difficulty with application, perceived control, and willingness to choose the same pain-control method in the future, will be reported descriptively based on categorical responses (Yes/No/Unsure)
Completed by the patient immediately after the procedure (within 30 mins post procedure).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mount Sinai Hospital, Canada

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juli 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 augustus 2026

Eerst geplaatst (Werkelijk)

17 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

11 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • REB # 1630

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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