Clinical trial NCT03111342: Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion
Official title: Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Anesthesia, Local
IUD Insertion Complication
Keywords: Intrauterine contraception
Pain
Anesthesia
LNG-IUD
nulligravida
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2017-04-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain associated with LNG-IUS insertion using VAS
timeFrame: Immediately following LNG-IUS insertion
Secondary outcomes:
measure: Pain associated with LNG-IUS insertion using face scale
timeFrame: Immediately following LNG-IUS insertion
measure: Pain associated with tenaculum placement using VAS
timeFrame: Immediately following tenaculum placement
measure: Pain associated with tenaculum placement using faces scale
timeFrame: Immediately following tenaculum placement
measure: Ease of IUS insertion
timeFrame: Immediately following LNG-IUS insertion
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Carolina S Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: