Anesthesia, Local, IUD Insertion Complication, Pain, Acute
Conditions
Keywords
Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida
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.
Interventions
DRUGAnesthesia
A 2% lidocaine without vasoconstrictor injection into the cervix
PROCEDUREDry-needling
A placement of thin needle into the cervix without substance injection
Sponsors
University of Campinas, Brazil
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The care provider will open the randomization envelope and will do one of three possible approaches (a intracervical lidocaine injection, a intracervical dry needling or no intervention). Then, a second care provider will insert the intrauterine contraceptive (IUC) blinding for the approach of the first care provider. After IUC insertion, the latter care provider will assess the pain felt by the woman using proper scales. The woman will be also blinded to the approach used before IUC insertion.
Intervention model description
Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with LNG-IUS insertion using VAS | Immediately following LNG-IUS insertion | To evaluate pain scores using the visual analog scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 VAS | Immediately following tenaculum placement | To evaluate pain scores using the visual analog scale (VAS) |
| 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) |
| Ease of IUS insertion | Immediately following LNG-IUS insertion | To evaluate ease of LNG-IUS insertion rated by the provider |
Countries
Brazil
Outcome results
None listed