Clinical trial NCT02155166: Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Levonorgestrel-releasing intrauterine system
anesthesia
pain
nulliparous
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: immediately after LNG-IUS insertion (approx 1 sec)
Secondary outcomes:
measure: Pain
timeFrame: 2 and 6 hours after the LNG-IUS insertion
measure: Discomfort
timeFrame: immediately after LNG-IUS insertion (approx 1 sec)
measure: ease of insertion
timeFrame: immediately after LNG-IUS insertion (approx 1 sec)
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: CAROLINA S VIEIRA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro TV, Franceschini SA, Poli-Neto O, Ferriani RA, Silva de Sa MF, Vieira CS. Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel-releasing intrauterine system in women without previous vaginal delivery: a RCT. Hum Reprod. 2014 Nov;29(11):2439-45. doi: 10.1093/humrep/deu233. Epub 2014 Sep 19.