Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06960317

Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment

Led by University of California, San Diego · Updated on 2025-06-13

204

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how different methods of using a numbing medication called lidocaine affect pain during the placement of an intrauterine device (IUD) in women aged 18 to 50. The study also evaluates how patients perceive their clinicians' empathy during the procedure. This research focuses on whether buffered lidocaine, unbuffered lidocaine, or medicated gel can reduce pain for women, including those with prior C-sections or no previous delivery. Participants may receive one of several treatments before IUD placement: a buffered lidocaine paracervical block injection, an unbuffered lidocaine injection, a sham procedure with a capped needle, or application of a medicated or non-medicated gel. The lidocaine is administered near the cervix to numb the area, and the study compares these different approaches to understand their impact on pain relief and patient experience. During the procedure, participants will complete questionnaires rating their pain and satisfaction, as well as their feelings about clinician empathy. Pain scores are measured from when the speculum is placed until five minutes after the procedure. The study monitors these outcomes carefully to gather detailed information about pain control and patient perceptions. Participation includes the procedure visit and follow-up assessments up to five minutes post-procedure.

CONDITIONS

Brief Title

Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Women seeking IUD placement for contraception or heavy menstrual bleeding
  • Ages 18 to 50 years
  • English-speaking
  • No past medical history of substance use disorders, pain disorders, or use of prescription pain medications
  • Not currently pregnant
Not Eligible

You will not qualify if you...

  • No history of vaginal delivery
  • Current use of prescription pain medication prior to procedure
  • Diagnosed chronic pain condition
  • Current pregnancy
  • Known allergies to components of the local anesthetic
  • History of previous IUD placement
  • Current or past substance use
  • Known contraindications to IUD such as unexplained vaginal bleeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants receive a paracervical block or gel prior to IUD placement and complete questionnaires assessing pain, satisfaction, and perceived clinician empathy during the procedure.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of California, San Diego

La Jolla, California, United States, 92093

Actively Recruiting

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Research Team

M

Marisa Hildebrand, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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Published Research Related To This Trial

The effects of injections of warmed bicarbonate-buffered Lidocaine as a painkiller for patients with trauma.

Reza Azizkhani, Mohsen Forghani, Asieh Maghami-Mehr...

https://pubmed.ncbi.nlm.nih.gov/24879075

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

Sheila K Mody, John Paul Farala, Berenice Jimenez...

https://pubmed.ncbi.nlm.nih.gov/30095776

Double-blind, bilateral pain comparison with simultaneous injection of 2% lidocaine versus buffered 2% lidocaine for periocular anesthesia.

Mark N Welch, Craig N Czyz, Kevin Kalwerisky...

https://pubmed.ncbi.nlm.nih.gov/22771049

Prospective randomized evaluation of short-term complications when using buffered or unbuffered lidocaine 1% with epinephrine for blepharoplasty surgery.

Julio Narváez, Izak Wessels, Gregory Bacon...

https://pubmed.ncbi.nlm.nih.gov/20090482

A prospective, randomized, double-blind comparison of the injection pain and anesthetic onset of 2% lidocaine with 1:100,000 epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations.

Paul Hobeich, Stephen Simon, Emit Schneiderman...

https://pubmed.ncbi.nlm.nih.gov/23611375

Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study.

Taryn Kratz Harreld, Sara Fowler, Melissa Drum...

https://pubmed.ncbi.nlm.nih.gov/26253800