N/A N=67 Randomized Single-blind Treatment

Pain Control for Intrauterine Device Placement Using Paracervical Block

Pain Due to Intrauterine Contraceptive Device

Bottom Line

View on ClinicalTrials.gov: NCT02219308 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Pain With Intrauterine Device (IUD) Placement — 54; 33 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paracervical Block (PCB) (Procedure); No Paracervical Block (Sham PCB) (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Diego
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain With Intrauterine Device (IUD) Placement	54; 33	—
SECONDARY Median Pain Scores for All Time Points	51; 58; 0; 0; 6; 10	—

Summary

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Eligibility Criteria

Inclusion Criteria

Nulliparous women
English or Spanish speaking
Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

Exclusion Criteria

Pregnancy
Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
Misoprostol administration within 24 hours of enrollment
History of prior IUD insertion
Known contraindications to IUD

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02219308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.