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Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o

NCT03636451 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-04-20

Study results available
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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.

Conditions

  • Abortion, Spontaneous
  • Abortion in First Trimester
  • Pain Uterus
  • Abortion Early
  • Abortion, Missed

Interventions

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

Principal Investigators

  • Sheila K Mody, MD MPH · UCSD Department of Ob/Gyn and Reproductive Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2020-12-14
Completion
2022-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636451 on ClinicalTrials.gov