Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement

NCT06974032 | Not Yet Recruiting

• 1 other identifier: 812588
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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 patients' opinions of their clinicians' empathy. The investigators are inviting patients who have never given birth who arrive at their clinic visit seeking an IUD. Usually, at University of California, San Diego (UCSD), for patients who have never delivered, clinicians numb both the sides of the cervix with a lidocaine-based paracervical block. The purpose of this research study is to compare perceptions of pain between lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.

Conditions

Contraception; Pain, Acute; Anesthesia, Local

Outcome Measures

Primary Outcomes (2)

• Pain scores during IUD placement procedure

  Does 2% lidocaine jelly decrease pain of paracervical block injection before IUD placement procedures among nulliparous women? 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

• Patient perceptions of clinician empathy

  What is the relationship between pain and feelings about clinician empathy? Empathy will be measured through answers to the 10-question Consultation and Relational Empathy (CARE) Measure. Each question is answered by a 5-point scale of how well the patient believes their clinician to be at various types of empathetic gestures, where 1 equals "poor" and 5 equals "excellent."

  From pre-procedure baseline to 5 minutes post-procedure

Study Arms (2)

2% lidocaine gel (Xylocaine)

EXPERIMENTAL

Experimental group: will receive 6cc of 2 lidocaine gel (Xylocaine) administered vaginally before paracervical block for IUD placement

Drug: Xylocaine jelly 2%

Non-Medicated Gel (Surgilube)

PLACEBO COMPARATOR

Placebo group: will receive 6cc of non-medicated (surgilube) gel administered vaginally before paracervical block for IUD placement

Drug: Surgilube

Interventions

Xylocaine jelly 2% DRUG

To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women

2% lidocaine gel (Xylocaine)

Surgilube DRUG

To determine if the placebo gel increases pain of paracervical block injection before IUD placement in nulliparous women

Non-Medicated Gel (Surgilube)

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 presenting for 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
• Nulliparous (never given birth)

You may not qualify if:

• History of ever giving birth
• 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

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: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not know their group assignment. Clinicians will not know which group the participant is in. The gel will be prepared by another member of the research team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-armed double-blind, randomized controlled

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share