drugset / Trial / NCT01214161

Intracervical Lidocaine Gel for IUD Insertional Pain

NCT01214161 ↗

Completed 200 enrolled Columbia University
RandomizedParallel-groupTriple-blindSupportive care

Summary

The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain

Timeline

Start
2010-10
Primary completion
2011-03
Completion
2013-06

Outcome

Missed primary endpoint

paper Intracervical 2% lidocaine gel does not decrease IUD insertion pain. PMID 22325115 ↗

paper Pain was greatest at uterine sounding and similar between groups: placebo group mean 51.6 mm (SD 25), lidocaine group mean 55.5 mm (SD 30, p=.33). PMID 22325115 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 1 ml —
Subject Lidocaine Other / unclassified 2 % —

Indications

No indication recorded.