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Completed

NCT Number: NCT02155166

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intracervical anesthesia with lidocaine 2%

Drug

5 min before LNG-IUS placemen

Ibuprofen 400 mg

Drug

1 hour prior to the LNG-IUS insertion

Primary outcomes

  1. Pain

    Time frame: immediately after LNG-IUS insertion (approx 1 sec)

    Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale)

Secondary outcomes

  1. Pain

    Time frame: 2 and 6 hours after the LNG-IUS insertion

    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. Discomfort

    Time frame: immediately after LNG-IUS insertion (approx 1 sec)

    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)

  3. ease of insertion

    Time frame: immediately after LNG-IUS insertion (approx 1 sec)

    To evaluated the ease of insertion of the LNG-IUS (as rated by the provider)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 4, 2014
Registry last updated
Jan 21, 2015

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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