EMLA Cream in Hysteroscopy Practice

NCT02640183 | Unknown Phase 2

• 1 other identifier: EMLA-Hsc
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.

Conditions

Anesthetics, Local

Outcome Measures

Primary Outcomes (1)

• Pain experienced during the procedure scored using a VAS.

  All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure. After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed.

  Procedure

Study Arms (2)

Group A (EMLA)

EXPERIMENTAL

3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

Drug: EMLA

Group B (Placebo)

PLACEBO COMPARATOR

3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

Other: Placebo

Interventions

EMLA DRUG

Group A (EMLA)

Placebo OTHER

Also known as: Ultrasound gel

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that must perform a diagnostic hysteroscopy.
• Acceptance to participate in the study.
• Signed informed consent.
• Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
• Absence of sedative use 24 h before admission

You may not qualify if:

• Hypersensitivity or allergy to anesthetics
• refusal of the patient
• Patients under age 18 and pregnant.
• Patients on anti-arrhythmic drugs due to possibility of drug interaction.
• Unbearable pain that involves other analgesic measures.
• Allergic reactions to topical anesthetics

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TA

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 28, 2015

Record last verified: 2015-12