ContraceptionEPICNCT06960317
Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements
A study testing Buffered Lidocaine, Unbuffered lidocaine and Xylocaine jelly 2% in people with Contraception and Pain, Acute, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Pain, Acute, Anesthesia, Local
- What is being tested?
- Buffered Lidocaine, Unbuffered lidocaine and Xylocaine jelly 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Marisa Hildebrand, MPH, familyplanningresearch@ucsd.edu
Sheila Mody, MD, MPH
About this study
Official title: Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
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.
Read the detailed description
Lidocaine is a drug that has been approved by the Food and Drug Administration (FDA). Sodium bicarbonate is an additive that buffers the acidity of lidocaine. The combination of the two is safe and effective as a paracervical block for pain relief in various OBGYN procedures. At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement.
Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel.
Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown.
- Conditions
- Contraception, Pain, Acute, Anesthesia, Local
- Being tested
- Buffered Lidocaine, Sham Comparator, Unbuffered lidocaine, Xylocaine jelly 2%, Surgilube
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered LidocaineDrug
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 ComparatorOther
None - capped needle will not be injected nor will it contain any medication.
Unbuffered lidocaineDrug
To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
Xylocaine jelly 2%Drug
To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block
SurgilubeDrug
To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Unbuffered lidocaine |
| 3a: Medicated gel | Experimental | Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block. Receives: Drug: Xylocaine jelly 2% |
| 3b: Non-medicated gel | Placebo comparator | Placebo group: will receive a non-medicated gel prior to administration of paracervical block. Receives: Drug: Surgilube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: From speculum placement to 5 minutes post-procedure
Secondary outcomes (1)
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."
Measured: From pre-procedure baseline to 5 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start4 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6-armed single-blind randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila K Mody, MD, MPH, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960317
- Sponsor's protocol ID
- 812390
- Acronym
- EPIC
- Status last verified
- Jun 2025
- First submitted
- 16 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33196038Azizkhani 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.
PubMed 24879075Mody 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.
PubMed 30095776Welch 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.
PubMed 22771049Narvaez 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.
PubMed 20090482Hobeich 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.
PubMed 23611375Harreld 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.
PubMed 26253800Maguire 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.
PubMed 22325115Allen 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.
PubMed 24012096
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
- ClinicalTrials.gov ID
- NCT06960317
- Acronym / sponsor ID
- EPIC / 812390
- Conditions
- Contraception, Pain, Acute, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lidocaine is a drug that has been approved by the Food and Drug Administration (FDA). Sodium bicarbonate is an additive that buffers the acidity of lidocaine. The combination of the two is safe and effective as a paracervical block for pain relief in various OBGYN procedures. At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement.
Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel.
Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- 6-armed single-blind randomized controlled
| Arm | Type | Receives |
|---|---|---|
| 1a: Buffered lidocaine paracervical block | Experimental | Drug: Buffered LidocaineTreatment 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. |
| 1b: Capped needle | Sham comparator | Other: Sham ComparatorSham 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. |
| 2a: Buffered lidocaine paracervical block | Experimental | Drug: Buffered LidocaineTreatment 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. |
| 2b: Unbuffered lidocaine paracervical block | Active comparator | Drug: Unbuffered lidocaineActive 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. |
| 3a: Medicated gel | Experimental | Drug: Xylocaine jelly 2%Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block. |
| 3b: Non-medicated gel | Placebo comparator | Drug: SurgilubePlacebo group: will receive a non-medicated gel prior to administration of paracervical block. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buffered LidocaineTo determine if a 20 cc buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) lidocaine paracervical block decreases pain with IUD placement | Drug | 1a: Buffered lidocaine paracervical block, 2a: Buffered lidocaine paracervical block |
| Sham ComparatorNone - capped needle will not be injected nor will it contain any medication. | Other | 1b: Capped needle |
| Unbuffered lidocaineTo determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement | Drug | 2b: Unbuffered lidocaine paracervical block |
| Xylocaine jelly 2%To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block | Drug | 3a: Medicated gel |
| SurgilubeTo determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block | Drug | 3b: Non-medicated gel |
Primary outcome
Pain scores during IUD placement procedure
Time frame: From speculum placement to 5 minutes post-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."
1 secondary outcome
Patient perceptions of clinician empathy
Time frame: From pre-procedure baseline to 5 minutes post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 33196038Chin 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.
- Background: PubMed 24879075Azizkhani 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.
- Background: PubMed 30095776Mody 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.
- Background: PubMed 22771049Welch 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.
- Background: PubMed 20090482Narvaez 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.
- Background: PubMed 23611375Hobeich 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.
- Background: PubMed 26253800Harreld 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.
- Background: PubMed 22325115Maguire 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.
- Background: PubMed 24012096Allen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheila K Mody, MD, MPH principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffered Lidocaine, Unbuffered lidocaine and Xylocaine jelly 2% in people with Contraception and Pain, Acute, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisa Hildebrand, MPH ((858) 657-8745, mchildeb@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores during IUD placement procedure (time frame: From speculum placement to 5 minutes post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06960317, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.