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

Study Overview
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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

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.

Official Title
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Effect of Injectable Intracervical Anesthesia on the Pain Associated With the Insertion of the Levonorgestrel-releasing Intrauterine System in Women Without Previous Vaginal Delivery: a Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Intracervical anesthesia with lidocaine 2%
* Drug: ibuprofen 400 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intracervical anesthesia<br>Intracervical anesthesia with lidocaine 2% | Drug: Intracervical anesthesia with lidocaine 2%<br>* 5 min before LNG-IUS placemen<br>|
| Active Comparator: ibuprofen<br>ibuprofen 400 mg | Drug: ibuprofen 400 mg<br>* 1 hour prior to the LNG-IUS insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale) | immediately after LNG-IUS insertion (approx 1 sec) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | immediately after LNG-IUS insertion (approx 1 sec) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levonorgestrel-releasing intrauterine system, anesthesia, pain, nulliparous