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EMLA Cream as Analgesic for Outpatient Gynecological Procedures

Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial

Status
Enrolling by invitation
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05970354
Enrollment
400
Registered
2023-08-01
Start date
2023-09-15
Completion date
2025-02-28
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

intra-uterine device insertion, hysteroscopy, endometrial biopsy

Brief summary

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is: • Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy? Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

Detailed description

Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.

Interventions

Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)

Sponsors

CAMC Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies

Exclusion criteria

* Known hypersensitivity to amide anesthetics * Pre-existing methemoglobinemia

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale Pain Score 1At time of speculum placement for procedureScale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 2At start of cervical manipulationScale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 32 minutes after speculum removalScale of 0-10 on a self-reported pain score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026