Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

Pain, Acute Clinical Trial

Official title:

Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111342
• Other study ID #: Pain LNG-IUS
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 31, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

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).

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Local
• IUD Insertion Complication
• Pain, Acute

Intervention

Drug:
• Anesthesia
A 2% lidocaine without vasoconstrictor injection into the cervix

Procedure:
• Dry-needling
A placement of thin needle into the cervix without substance injection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain associated with LNG-IUS insertion using VAS	To evaluate pain scores using the visual analog scale (VAS)	Immediately following LNG-IUS insertion
Secondary	Pain associated with LNG-IUS insertion using face scale	To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)	Immediately following LNG-IUS insertion
Secondary	Pain associated with tenaculum placement using VAS	To evaluate pain scores using the visual analog scale (VAS)	Immediately following tenaculum placement
Secondary	Pain associated with tenaculum placement using faces scale	To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)	Immediately following tenaculum placement
Secondary	Ease of IUS insertion	To evaluate ease of LNG-IUS insertion rated by the provider	Immediately following LNG-IUS insertion