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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02155166

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

100

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Intracervical anesthesia with lidocaine 2% Drug: ibuprofen 400 mg	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intracervical anesthesia Intracervical anesthesia with lidocaine 2%	Drug: Intracervical anesthesia with lidocaine 2% 5 min before LNG-IUS placemen
Active Comparator: ibuprofen ibuprofen 400 mg	Drug: ibuprofen 400 mg 1 hour prior to the LNG-IUS insertion

Arm

Intervention/Treatment

Active Comparator: intracervical anesthesia

Intracervical anesthesia with lidocaine 2%

Drug: Intracervical anesthesia with lidocaine 2%

5 min before LNG-IUS placemen

Active Comparator: ibuprofen

ibuprofen 400 mg

Drug: ibuprofen 400 mg

1 hour prior to the LNG-IUS insertion

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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