Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

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

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Pain, Acute Anesthesia, Local IUD Insertion Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The care provider will open the randomization envelope and will do one of three possible approaches (a intracervical lidocaine injection, a intracervical dry needling or no intervention). Then, a second care provider will insert the intrauterine contraceptive (IUC) blinding for the approach of the first care provider. After IUC insertion, the latter care provider will assess the pain felt by the woman using proper scales. The woman will be also blinded to the approach used before IUC insertion.

Study Groups

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Anesthesia

A 2% lidocaine without vasoconstrictor injection into the cervix

Group Type EXPERIMENTAL

Anesthesia

Intervention Type DRUG

A 2% lidocaine without vasoconstrictor injection into the cervix

Dry-needling

A placement of thin needle into the cervix without substance injection

Group Type SHAM_COMPARATOR

Dry-needling

Intervention Type PROCEDURE

A placement of thin needle into the cervix without substance injection

No intervention

No intervention for pain relief prior to LNG-IUS insertion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anesthesia

A 2% lidocaine without vasoconstrictor injection into the cervix

Intervention Type DRUG

Dry-needling

A placement of thin needle into the cervix without substance injection

Intervention Type PROCEDURE

Other Intervention Names

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2% lidocaine without vasoconstritor

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes