Phase 3
N=114
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Abortion, Spontaneous · Abortion in First Trimester · Pain Uterus · Abortion Early · Abortion, Missed
Bottom Line
View on ClinicalTrials.gov: NCT03636451 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Pain With Cervical Dilation — 52; 45 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block (Drug); 20cc 1% lidocaine with 2 units of vasopressin paracervical block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain With Cervical Dilation |
52; 45 | — |
| SECONDARY Pain With Uterine Aspiration |
46; 58 | — |
| SECONDARY Pain 10 Minutes Post Procedure |
26; 11 | — |
| SECONDARY Overall Pain |
57; 56 | — |
Summary
The investigators are conducting a study on pain control for dilation and curettage (D&C). Participants are eligible to enroll if they are a planning to have a D&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. Both potential methods use the same dose of medication, though researchers would like to know which one works better. To be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing D&C while awake in clinic.
Eligibility Criteria
Inclusion Criteria
- Women over the age of 18 presenting to UC San Diego and UC Los Angeles
- Undesired pregnancy or missed abortion < 11 weeks 6 days gestation
- Must speak English or Spanish
- Desire surgical termination of pregnancy or management of miscarriage in clinic
Exclusion Criteria
- Women with a diagnosis of inevitable or incomplete abortion
- Desire for general anesthesia or IV sedation
- Chronic pain conditions
- Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
- Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
- If they have taken any pain medications the day of presentation to clinic
- If they have taken Misoprostol the day of presentation to clinic
Data sourced from ClinicalTrials.gov (NCT03636451). 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.