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

NCT02155166 | Completed

• 1 other identifier: LNG-IUS-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

Levonorgestrel-releasing intrauterine system; anesthesia; pain; nulliparous

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Pain

  2 and 6 hours after the LNG-IUS insertion

• Discomfort

  immediately after LNG-IUS insertion (approx 1 sec)

• ease of insertion

  immediately after LNG-IUS insertion (approx 1 sec)

Study Arms (2)

intracervical anesthesia

ACTIVE COMPARATOR

Intracervical anesthesia with lidocaine 2%

Drug: Intracervical anesthesia with lidocaine 2%

ibuprofen

ACTIVE COMPARATOR

ibuprofen 400 mg

Drug: ibuprofen 400 mg

Interventions

Intracervical anesthesia with lidocaine 2% DRUG

5 min before LNG-IUS placemen

intracervical anesthesia

ibuprofen 400 mg DRUG

1 hour prior to the LNG-IUS insertion

ibuprofen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients who wanted to use the LNG-IUS as a contraceptive
• age between 18 and 45 years
• nulliparity
• absence of previous vaginal delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25240012 RESULT

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• CAROLINA S VIEIRA, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

BR (1)