Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial.
Jennifer Chin, Bliss Kaneshiro, Jennifer Elia...
https://pubmed.ncbi.nlm.nih.gov/33196038/Actively Recruiting
Led by University of California, San Diego · Updated on 2025-06-13
204
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying how different methods of using a numbing medication called lidocaine affect pain during the placement of an intrauterine device IUD in women aged 18 to 50. The study also evaluates how patients perceive their clinicians empathy during the procedure. This research focuses on whether buffered lidocaine, unbuffered lidocaine, or medicated gel can reduce pain for women, including those with prior C-sections or no previous delivery. Participants may receive one of several treatments before IUD placement a buffered lidocaine paracervical block injection, an unbuffered lidocaine injection, a sham procedure with a capped needle, or application of a medicated or non-medicated gel. The lidocaine is administered near the cervix to numb the area, and the study compares these different approaches to understand their impact on pain relief and patient experience. During the procedure, participants will complete questionnaires rating their pain and satisfaction, as well as their feelings about clinician empathy. Pain scores are measured from when the speculum is placed until five minutes after the procedure. The study monitors these outcomes carefully to gather detailed information about pain control and patient perceptions. Participation includes the procedure visit and follow-up assessments up to five minutes post-procedure.
CONDITIONS
Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements
M
Marisa Hildebrand, MPH
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University of California, San Diego
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Buffered Lidocaine Paracervical Block | Unbuffered Lidocaine Paracervical Block |
|---|---|---|
| What it is | An injection of lidocaine with added sodium bicarbonate administered as a paracervical block just before IUD placement, intended to numb the cervix and reduce pain. | An injection of 1% lidocaine (without sodium bicarbonate) given as a paracervical block before IUD placement for procedural pain control. |
| Role in trial | Investigational method to reduce pain during IUD placement, evaluated against unbuffered lidocaine. | Active comparator using standard unbuffered lidocaine, reflecting current clinical pain control practice. |
| Primary use | Intended to reduce pain for women having an IUD placed, by buffering lidocaine with sodium bicarbonate. | Used to numb the cervix and manage procedural pain during IUD insertion. |
| How it is given or performed | Injected as a paracervical block containing lidocaine and sodium bicarbonate immediately prior to IUD insertion. | Injected as a paracervical block with lidocaine only, just before the IUD is placed. |
| Evidence status | Evidence from other gynecologic procedures suggests buffering lidocaine can reduce pain with injection. Published studies in similar settings (such as abortion or incision and drainage) found buffered solutions result in lower pain scores during block administration and procedures, but direct evidence for IUD insertion is limited and the current trial is in progress. | Unbuffered lidocaine paracervical block is well studied and widely used for IUD placement. Randomized trials demonstrate some reduction in procedural pain, but effectiveness is modest, and additional strategies are often investigated. |
| Important limitations | Direct evidence for pain relief with buffered lidocaine in IUD placement is limited. Buffering may add time and require extra preparation during office procedures. The ongoing trial will provide better efficacy data. | Pain reduction from unbuffered lidocaine is only moderate and many women still find IUD placement uncomfortable. Some studies report limited difference compared to placebo for certain pain measures. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive a paracervical block or gel prior to IUD placement and complete questionnaires assessing pain, satisfaction, and perceived clinician empathy during the procedure.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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https://pubmed.ncbi.nlm.nih.gov/20090482/University of California, San Diego
Lead Sponsor