Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Anesthesia, Local; IUD Insertion Complication; Pain, Acute

Treatments: Drug: Anesthesia; Procedure: Dry-needling

Study type: Interventional

Funder types: Other

Identifiers

NCT03111342

Pain LNG-IUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

Anesthesia

Experimental group

Description:

A 2% lidocaine without vasoconstrictor injection into the cervix

Treatment:

Drug: Anesthesia

Dry-needling

Sham Comparator group

Description:

A placement of thin needle into the cervix without substance injection

Treatment:

Procedure: Dry-needling

No intervention

No Intervention group

Description:

No intervention for pain relief prior to LNG-IUS insertion