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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155166
• Other study ID #: LNG-IUS-2
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: January 17, 2015
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Intracervical anesthesia with lidocaine 2%
5 min before LNG-IUS placemen
• ibuprofen 400 mg
1 hour prior to the LNG-IUS insertion

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirão Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Castro TV, Franceschini SA, Poli-Neto O, Ferriani RA, Silva de Sá 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale)	immediately after LNG-IUS insertion (approx 1 sec)	No
Secondary	Pain	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 and 6 hours after the LNG-IUS insertion	No
Secondary	Discomfort	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)	immediately after LNG-IUS insertion (approx 1 sec)	No
Secondary	ease of insertion	To evaluated the ease of insertion of the LNG-IUS (as rated by the provider)	immediately after LNG-IUS insertion (approx 1 sec)	No