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

University of Sao Paulo

Status

Completed

Conditions

Pain

Treatments

Drug: Intracervical anesthesia with lidocaine 2%

Drug: ibuprofen 400 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02155166

LNG-IUS-2

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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