Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

Study Overview
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Brief Summary
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The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.

Detailed Description
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No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.

Official Title
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Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial

Conditions
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Pain, Acute, Anesthesia, Local, IUD Insertion Complication

Intervention / Treatment
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* Drug: Anesthesia
* Procedure: Dry-needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 45 years; That were never pregnant before; That wants to use LNG-IUD; Not pregnant at the time of insertion; No haematological disease; That do not have signs and / or symptoms of vaginal / cervical infection. Exclusion Criteria: Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).

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
Interventional Model Description: Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthesia<br>A 2% lidocaine without vasoconstrictor injection into the cervix | Drug: Anesthesia<br>* A 2% lidocaine without vasoconstrictor injection into the cervix<br>* Other names: 2% lidocaine without vasoconstritor;|
| Sham Comparator: Dry-needling<br>A placement of thin needle into the cervix without substance injection | Procedure: Dry-needling<br>* A placement of thin needle into the cervix without substance injection<br>|
| No Intervention: No intervention<br>No intervention for pain relief prior to LNG-IUS insertion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with LNG-IUS insertion using VAS | To evaluate pain scores using the visual analog scale (VAS) | Immediately following LNG-IUS insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with LNG-IUS insertion using face scale | To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP) | Immediately following LNG-IUS insertion | 
| Pain associated with tenaculum placement using VAS | To evaluate pain scores using the visual analog scale (VAS) | Immediately following tenaculum placement | 
| Pain associated with tenaculum placement using faces scale | To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP) | Immediately following tenaculum placement | 
| Ease of IUS insertion | To evaluate ease of LNG-IUS insertion rated by the provider | Immediately following LNG-IUS insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida