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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marisa Hildebrand, MPH | Contact | (858) 657-8745 | mchildeb@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sheila K Mody, MD, MPH | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33196038 | Background | 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. | |
| 24879075 | 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. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008371 | phenylmercury borate |
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6-armed single-blind randomized controlled
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Participants will not know their group assignment. The clinicians will know which group the participant is in.
| 3a: Medicated gel | Experimental | Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block. |
|
| 3b: Non-medicated gel | Placebo Comparator | Placebo group: will receive a non-medicated gel prior to administration of paracervical block. |
|
| Sham Comparator | Other | None - capped needle will not be injected nor will it contain any medication. |
|
| Unbuffered lidocaine | Drug | 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 |
|
| Surgilube | Drug | To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block |
|
| From pre-procedure baseline to 5 minutes post-procedure |
| 30095776 | 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. |
| 22771049 | 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. |
| 20090482 | 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. |
| 23611375 | 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. |
| 26253800 | 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. |
| 22325115 | 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. |
| 24012096 | 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. |