University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900, Brazil
NCT Number: NCT03111342
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Phase 4
Ribeirão Preto, São Paulo, 14049-900, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 2% lidocaine without vasoconstrictor injection into the cervix
Other names: 2% lidocaine without vasoconstritor
A placement of thin needle into the cervix without substance injection
Time frame: Immediately following LNG-IUS insertion
To evaluate pain scores using the visual analog scale (VAS)
Time frame: Immediately following LNG-IUS insertion
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Time frame: Immediately following tenaculum placement
To evaluate pain scores using the visual analog scale (VAS)
Time frame: Immediately following tenaculum placement
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Time frame: Immediately following LNG-IUS insertion
To evaluate ease of LNG-IUS insertion rated by the provider
University of Sao Paulo
Other
Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT05476575
Acute Pain, Neurologic Manifestations
New Taipei City, Taiwan
View Trial DetailsNCT06062108
Acute Pain, Chronic Pain
Draguignan, Var, France
View Trial DetailsNCT07616869
Acute Pain, Anxiety Disorders
Manisa, Yunusemre, Turkey (Türkiye)
View Trial Details