Phase 4
N=98
Buffered Lidocaine in Paracervical Blocks
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03107754 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Injection Pain — 44.5; 30 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); Lidocaine-Sodium Bicarbonate (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University of Hawaii
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Pain |
44.5; 30 | — |
| SECONDARY Pain After Speculum Placement, Cervical Dilation, and Aspiration |
13; 17; 60.06; 55; 67.5; 69 | — |
Summary
For pain relief during a first trimester surgical aspiration, most providers use the paracervical block, either alone or in combination with other pain control techniques. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered versus unbuffered lidocaine for paracervical blocks during first trimester uterine aspirations. This study seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.
Eligibility Criteria
Inclusion Criteria
- Pregnant women 14 years and older
- Desiring uterine aspiration for pregnancy or surgical management of a miscarriage
- Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last menstrual period or earliest ultrasound)
- Treatment plan involves outpatient uterine aspiration
- Participant able to provide informed consent in English and willing to participate in the study
Exclusion Criteria
- Unable to read, speak, or understand English
- Unable to provide informed consent
- Currently incarcerated
- Under the age of 14 years
- Contraindications to receiving lidocaine or buffered lidocaine
Data sourced from ClinicalTrials.gov (NCT03107754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.