Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

University of Sao Paulo300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Pain, Acute Anesthesia, Local IUD Insertion Complication

Interventions

AnesthesiaDRUG

A 2% lidocaine without vasoconstrictor injection into the cervix

Dry-needlingPROCEDURE

A placement of thin needle into the cervix without substance injection

Eligibility

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

Medical Language ↔ Plain English

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).

Locations (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Pain associated with LNG-IUS insertion using VAS

To evaluate pain scores using the visual analog scale (VAS)

Time frame: Immediately following LNG-IUS insertion

Secondary Outcomes

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)

Time frame: Immediately following LNG-IUS insertion

Pain associated with tenaculum placement using VAS

To evaluate pain scores using the visual analog scale (VAS)

Time frame: 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)

Time frame: Immediately following tenaculum placement

Ease of IUS insertion

To evaluate ease of LNG-IUS insertion rated by the provider

Time frame: Immediately following LNG-IUS insertion

Data from ClinicalTrials.gov

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