Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

Phase 4

Completed

• Conditions: Anesthesia, Local; Pain, Acute; IUD Insertion Complication
• Interventions: Drug: Anesthesia; Procedure: Dry-needling

• Registration Number: NCT03111342
• Lead Sponsor: University of Sao Paulo

Brief Summary

The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.

Detailed Description

No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-06-01
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Age between 18 and 45 years;
• That were never pregnant before;
• That wants to use LNG-IUD;
• Not pregnant at the time of insertion;
• No haematological disease;
• That do not have signs and / or symptoms of vaginal / cervical infection.

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Exclusion Criteria

• Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthesia	Anesthesia	A 2% lidocaine without vasoconstrictor injection into the cervix
Dry-needling	Dry-needling	A placement of thin needle into the cervix without substance injection

Primary Outcome Measures

Name	Time	Method
Pain associated with LNG-IUS insertion using VAS	Immediately following LNG-IUS insertion	To evaluate pain scores using the visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Pain associated with LNG-IUS insertion using face scale	Immediately following LNG-IUS insertion	To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Pain associated with tenaculum placement using faces scale	Immediately following tenaculum placement	To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Pain associated with tenaculum placement using VAS	Immediately following tenaculum placement	To evaluate pain scores using the visual analog scale (VAS)
Ease of IUS insertion	Immediately following LNG-IUS insertion	To evaluate ease of LNG-IUS insertion rated by the provider

Trial Locations

Locations (1)

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