EMLA Cream in Hysteroscopy Practice

Phase 2

• Conditions: Anesthetics, Local
• Interventions: Other: Placebo; Drug: EMLA

• Registration Number: NCT02640183
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-12
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Last Update Submitted: 2015-12-22
• Study First Posted: 2015-12-28
• Last Update Posted: 2015-12-28
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 184

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Placebo)	Placebo	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 A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.
Group A (EMLA)	EMLA	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 A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

Primary Outcome Measures

Name	Time	Method
Pain experienced during the procedure scored using a VAS.	Procedure	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.