CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block +1 moredrug
Likely dose
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical blockfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03636451
NCT03636451Phase 3Completed
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Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial

University of California, San Diego·interventional·Posted Aug 17, 2018·Updated Apr 20, 2023

In Brief

A Phase 3 clinical trial evaluating 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block and 20cc 1% lidocaine with 2 units of vasopressin paracervical block for Abortion, Spontaneous and 4 related conditions. Completed, enrolled 114 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion, Spontaneous, Abortion in First Trimester, Pain Uterus, Abortion Early, Abortion, Missed
CountriesUnited States
CollaboratorsSociety of Family Planning, University of California, Los Angeles

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartOct 29, 2018
Primary CompletionDec 14, 2020
Study CompletionSep 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.9 years ago

Interventions

40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical blockdrug

Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.

20cc 1% lidocaine with 2 units of vasopressin paracervical blockdrug

Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.