Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

NCT06960317 | Recruiting

• 1 other identifier: 812390
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain scores during IUD placement procedure

  Does buffered 1% lidocaine paracervical block decrease pain during IUD. placement procedures. Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means "No pain" and 10 means "Worst pain possible."

  From speculum placement to 5 minutes post-procedure

Secondary Outcomes (1)

• Patient perceptions of clinician empathy

  From pre-procedure baseline to 5 minutes post-procedure

Study Arms (6)

1a: Buffered lidocaine paracervical block

EXPERIMENTAL

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.

Drug: Buffered Lidocaine

1b: Capped needle

SHAM COMPARATOR

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.

Other: Sham Comparator

2a: Buffered lidocaine paracervical block

EXPERIMENTAL

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.

Drug: Buffered Lidocaine

2b: Unbuffered lidocaine paracervical block

ACTIVE COMPARATOR

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.

Drug: Unbuffered lidocaine

3a: Medicated gel

EXPERIMENTAL

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

Drug: Xylocaine jelly 2%

3b: Non-medicated gel

PLACEBO COMPARATOR

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

Drug: Surgilube

Interventions

Buffered Lidocaine DRUG

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

1a: Buffered lidocaine paracervical block; 2a: Buffered lidocaine paracervical block

Sham Comparator OTHER

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

1b: Capped needle

Unbuffered lidocaine DRUG

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

2b: Unbuffered lidocaine paracervical block

Xylocaine jelly 2% DRUG

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

3a: Medicated gel

Surgilube DRUG

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

3b: Non-medicated gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide informed consent
• Women IUD placement for contraception or heavy menstrual bleeding
• Ages 18-50
• English-speaking
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Publications (9)

• Chin J, Kaneshiro B, Elia J, Raidoo S, Savala M, Soon R. Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial. Contracept X. 2020 Oct 18;2:100044. doi: 10.1016/j.conx.2020.100044. eCollection 2020.

  PMID: 33196038 BACKGROUND

• Azizkhani R, Forghani M, Maghami-Mehr A, Masomi B. The effects of injections of warmed bicarbonate-buffered Lidocaine as a painkiller for patients with trauma. J Inj Violence Res. 2015 Jul;7(2):87-8. doi: 10.5249/jivr.v7i2.523. Epub 2013 Dec 12. No abstract available.

  PMID: 24879075 BACKGROUND

• Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.

  PMID: 30095776 BACKGROUND

• Welch MN, Czyz CN, Kalwerisky K, Holck DE, Mihora LD. Double-blind, bilateral pain comparison with simultaneous injection of 2% lidocaine versus buffered 2% lidocaine for periocular anesthesia. Ophthalmology. 2012 Oct;119(10):2048-52. doi: 10.1016/j.ophtha.2012.05.029. Epub 2012 Jul 6.

  PMID: 22771049 BACKGROUND

• Narvaez J, Wessels I, Bacon G, Chin VR, Baqai WK, Zimmerman GJ. Prospective randomized evaluation of short-term complications when using buffered or unbuffered lidocaine 1% with epinephrine for blepharoplasty surgery. Ophthalmic Plast Reconstr Surg. 2010 Jan-Feb;26(1):33-5. doi: 10.1097/IOP.0b013e3181b80c13.

  PMID: 20090482 BACKGROUND

• Hobeich P, Simon S, Schneiderman E, He J. 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. J Endod. 2013 May;39(5):597-9. doi: 10.1016/j.joen.2013.01.008. Epub 2013 Mar 20.

  PMID: 23611375 BACKGROUND

• Harreld TK, Fowler S, Drum M, Reader A, Nusstein J, Beck M. Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study. J Endod. 2015 Oct;41(10):1583-8. doi: 10.1016/j.joen.2015.06.017. Epub 2015 Aug 4.

  PMID: 26253800 BACKGROUND

• Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.

  PMID: 22325115 BACKGROUND

• Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.

  PMID: 24012096 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

phenylmercury borate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheila K Mody, MD, MPH

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Hildebrand, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know their group assignment. The clinicians will know which group the participant is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 6-armed single-blind randomized controlled

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 7, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)