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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: ibuprofen 400 mg; Drug: Intracervical anesthesia with lidocaine 2%

• Registration Number: NCT02155166
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-17
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen	ibuprofen 400 mg	ibuprofen 400 mg
intracervical anesthesia	Intracervical anesthesia with lidocaine 2%	Intracervical anesthesia with lidocaine 2%

Primary Outcome Measures

Name	Time	Method
Pain	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 Outcome Measures

Name	Time	Method
Pain	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)
Discomfort	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)
ease of insertion	immediately after LNG-IUS insertion (approx 1 sec)	To evaluated the ease of insertion of the LNG-IUS (as rated by the provider)

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Ribeirão Preto, SP, Brazil