Clinical trial NCT01967017: Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain
Official title: Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: IUD Insertion Complication
Pain Control
Keywords: Intrauterine device
Paracervical block
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.

Detailed description: The study will investigate the difference in perceived pain from IUD insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and "functionally nulliparous" women. The investigators plan a double-masked, placebo controlled, randomized clinical trial. The investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of a 15 mL 1% lidocaine paracervical block compared to patients who receive 15 mL of bacteriostatic saline (placebo).

Eligibility criteria: Inclusion Criteria:

* Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as \<4 cm dilation).
* English speaking

Exclusion Criteria:

* Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD
* chronic narcotic use, current or past history of illegal drug use (excluding marijuana)
* allergy to lidocaine

Primary outcomes:
measure: Pain at time of IUD insertion
timeFrame: During IUD insertion (no further follow up after patient leaves ofice)
Secondary outcomes:
measure: Pain at other time points of pelvic exam
timeFrame: During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office)
Other outcomes:
measure: Ease of insertion
timeFrame: Within 15 minutes of IUD insertion
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
References: