An interventional study of Buffered Lidocaine and Lidocaine 1% Injectable Solution in Contraception, Pain, Acute and Anesthesia, Local, sponsored by University of California, San Diego. Not yet recruiting. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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 buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) vs. unbuffered paracervical block (20 cc 1% lidocaine) during IUD placement for nulliparous women.
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 currently standard practice for people with no prior deliveries to receive a buffered lidocaine paracervical block prior to IUD placement.
Participants who take part in this study, will be randomly assigned to receive an injection of buffered lidocaine OR an injection of unbuffered lidocaine to numb the area before IUD placement.
Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will question participants about their pain levels, their satisfaction with the procedure, and how much empathy they feel the clinician has shown.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 68 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.
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Exclusion Criteria:
Experimental groups: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement.
Drug: Buffered Lidocaine
Active comparator group: will receive a 20-mL unbuffered (20 cc of 1% lidocaine) paracervical block administered before IUD placement.
Drug: Lidocaine 1% Injectable Solution
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 in nulliparous women
To determine if the unbuffered 1% lidocaine paracervical block offers any less pain control with IUD placement for nulliparous women
Pain scores during IUD placement procedure
Does buffered 1% lidocaine paracervical block decrease pain during 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."
Time frame: 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."
Time frame: From pre-procedure baseline to 5 minutes post-procedure
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2025; primary completion for Jun 2027, 24 months later.
Of 314 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's planned 24 months is above that.
Counting every sponsor, half of 318 studies reached it within 11 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buffered Lidocaine
University of California, San Diego →