Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-07-31

Brief Summary

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This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery.

H0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments

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Detailed Description

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Objective: To evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery. As secondary objectives, the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS insertion, the level of discomfort associated with the insertion procedure and the ease of insertion of the LNG-IUS will be evaluated.

Design: open randomized controlled trial Setting: Outpatient contraceptive services Patients: 100 women who want to use the LNG-IUS Interventions: 100 women will be randomized into two groups: a) use of a NSAID (ibuprofen, 400 mg) 1 hour before the LNG-IUS insertion; and b) 2% lidocaine intracervical injection. These women will be evaluated immediately after the LNG-IUS insertion, and then 2 hours and 6 hours after it.

Main outcome measures: Two pain scales will be used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort from the procedure (as rated by the patient). Multivariate logistic regression will be performed to analyze the predictors associated with moderate/severe pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intracervical anesthesia

Intracervical anesthesia with lidocaine 2%

Group Type ACTIVE_COMPARATOR

Intracervical anesthesia with lidocaine 2%

Intervention Type DRUG

5 min before LNG-IUS placemen

ibuprofen

ibuprofen 400 mg

Group Type ACTIVE_COMPARATOR

ibuprofen 400 mg

Intervention Type DRUG

1 hour prior to the LNG-IUS insertion

Interventions

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Intracervical anesthesia with lidocaine 2%

5 min before LNG-IUS placemen

Intervention Type DRUG

ibuprofen 400 mg

1 hour prior to the LNG-IUS insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients who wanted to use the LNG-IUS as a contraceptive
* age between 18 and 45 years
* nulliparity
* absence of previous vaginal delivery

Exclusion Criteria

* women in categories 3 and/or 4 for LNG-IUS use according to the medical eligibility criteria of the World Health Organization
* illicit drug and/or alcohol users
* women with allergies or contraindications to NSAIDs or lidocaine
* chronic pelvic pain of any etiology
* abnormalities in the cervix (such as fibrosis or isthmus-cervical incompetence)
* previous abortion with or without uterine curettage
* psychiatric disorders
* continued use of medications that could interfere with the pain threshold

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes