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Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel-releasing intrauterine system in nulliparous women: a randomized clinical trial

Grant number: 17/12938-4
Support type:Regular Research Grants
Duration: November 01, 2017 - October 31, 2019
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Omero Benedicto Poli Netto
Grantee:Omero Benedicto Poli Netto
Home Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
Assoc. researchers:Arlete Maria dos Santos Fernandes ; Carolina Sales Vieira ; Ilza Maria Urbano Monteiro ; Luis Guillermo Bahamondes


Introduction: 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. In a previous study, we 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. Objective: The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women. Methods: It is randomized clinical trial, double-blind, parallel study that will be conducted at two centers: Clinics Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo (HC-FMRP-USP) and Human Reproduction sector of the School of Medical Sciences, University of Campinas (UNICAMP). A total of 300 nulliparous women who have never been user of any intrauterine contraceptive (IUC) will be randomized into three groups: 1) intracervical injection of 2% lidocaine without vasoconstrictor; 2) dry needling (placement of thin needle into the cervix without substance injection); 3) without any intervention. The pain will be assessed by two scales immediately after the placement of LNG-IUS: the visual analog scale (VAS) and faces scale of the International Association for the Study of Pain (IASP). One doctor will do the intervention and the other will insert the LNG-IUS. We are going to use the James' blinding index (BI) and Bang's BI to evaluate the quality of the blinding. (AU)