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OpenTrials
Completed

NCT Number: NCT03111342

Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Anesthesia

Drug

A 2% lidocaine without vasoconstrictor injection into the cervix

Other names: 2% lidocaine without vasoconstritor

dry-needling

Procedure

A placement of thin needle into the cervix without substance injection

Primary outcomes

  1. Pain associated with LNG-IUS insertion using VAS

    Time frame: Immediately following LNG-IUS insertion

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

Secondary outcomes

  1. Pain associated with LNG-IUS insertion using face scale

    Time frame: Immediately following LNG-IUS insertion

    To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)

  2. Pain associated with tenaculum placement using VAS

    Time frame: Immediately following tenaculum placement

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

  3. Pain associated with tenaculum placement using faces scale

    Time frame: Immediately following tenaculum placement

    To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)

  4. Ease of IUS insertion

    Time frame: Immediately following LNG-IUS insertion

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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