NCT03111342

Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-08-30
• Completion: 2018-08-31
• First posted: 2017-04-12
• Last updated: 2019-08-01

Locations

1 site across 1 country: Brazil