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

University of Sao Paulo100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Pain

Interventions

Intracervical anesthesia with lidocaine 2%DRUG

5 min before LNG-IUS placemen

ibuprofen 400 mgDRUG

1 hour prior to the LNG-IUS insertion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Pain

Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale)

Time frame: immediately after LNG-IUS insertion (approx 1 sec)

Secondary Outcomes

Pain

To evaluate the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS placement (by by visual analogue scale and face scale)

Time frame: 2 and 6 hours after the LNG-IUS insertion

Discomfort

To evaluate the level of discomfort associated with the LNG-IUS insertion (By the experience of the patient in terms of LNG-IUS as slightly uncomfortable, uncomfortable, or very uncomfortable)

Time frame: immediately after LNG-IUS insertion (approx 1 sec)

ease of insertion

To evaluated the ease of insertion of the LNG-IUS (as rated by the provider)

Time frame: immediately after LNG-IUS insertion (approx 1 sec)

Data from ClinicalTrials.gov

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