Lidocaine-prilocaine Cream on IUD Insertion Pain

NCT ID: NCT02658773

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.

Detailed Description

IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain. Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed positive effect of 2% lidocaine gel, while others failed.

Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average duration of effective analgesia was 15 to 20 minutes.

Conditions

IUD Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

lidocaine-Prilocaine cream

lidocaine-Prilocaine anesthetic cream placed into their cervix prior to having the IUD inserted

Group Type: ACTIVE_COMPARATOR

lidocaine-Prilocaine cream

Intervention Type: DRUG

placebo cream

an inert placebo cream placed into their cervix

Group Type: PLACEBO_COMPARATOR

placebo cream

Intervention Type: DRUG

Interventions

lidocaine-Prilocaine cream

Intervention Type: DRUG

placebo cream

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women not taken analgesics or anxiolytics in the 24 hours prior insertion
• Women not taken misoprostol prior to IUD insertion
• No contraindication to or history of allergic reaction to lidocaine
• Women who will accept to participate in the study

Exclusion Criteria

• Lidocaine allergy
• Any contraindication to IUD placement

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

LPIUD

Identifier Type: -

Identifier Source: org_study_id