Recruiting

Buffered Paracervical Block

Sponsor:

UCLA

Code:

NCT06960317

Conditions

Contraception

Pain, Acute

Anesthesia, Local

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Buffered Lidocaine

Sham Comparator

Unbuffered lidocaine

Xylocaine jelly 2%

Surgilube

Study Details

Brief summary:

The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy.

The investigators are inviting patients who arrive at their clinic visit seeking an IUD.

Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.

Conditions

Contraception

Pain, Acute

Anesthesia, Local

Study ID

NCT06960317

Start date

Jun 4, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Ability to provide informed consent
2. Women IUD placement for contraception or heavy menstrual bleeding
3. Ages 18-50
4. English-speaking
5. Participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant

Exclusion Criteria:

1. No history of vaginal delivery
2. Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.
3. Diagnosed chronic pain condition
4. Current pregnancy
5. Known allergic reactions to components of the local anesthetic
6. History of an IUD placement
7. Current substance use or history of substance use
8. Known contraindications to IUD, such as unexplained vaginal bleeding

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1a: Buffered lidocaine paracervical block

Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.

sham comparator: 1b: Capped needle

Sham group: will receive a capped needle without any medication administered as paracervical block before IUD placement. They will receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.

experimental: 2a: Buffered lidocaine paracervical block

Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.

active comparator: 2b: Unbuffered lidocaine paracervical block

Active comparator group: will receive a 20-mL unbuffered (1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.

experimental: 3a: Medicated gel

Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block.

placebo comparator: 3b: Non-medicated gel

Placebo group: will receive a non-medicated gel prior to administration of paracervical block.

Interventions

Buffered Lidocaine

To determine if a 20 cc buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) lidocaine paracervical block decreases pain with IUD placement

Sham Comparator

None - capped needle will not be injected nor will it contain any medication.

Unbuffered lidocaine

To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement

Xylocaine jelly 2%

To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block

Surgilube

To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block

Primary outcome measure

  • Pain scores during IUD placement procedure [ Time Frame: From speculum placement to 5 minutes post-procedure ]

Central Contacts and Locations

Central contacts

Marisa Hildebrand, MPH

(858) 657-8745mchildeb@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Marisa Hildebrand, MPH

familyplanningresearch@ucsd.edu

Principal Investigator:

Sheila Mody, MD, MPH

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-06-13.