Summary

for females ages 18 years and up (full criteria)
healthy people welcome
at UCSD UCLA
study started
estimated completion:
Bonnie Crouthamel (ucsd)

Description

Summary

We are conducting a study on pain control for D&C. You are eligible to participate if you are a planning to have a D&C in our clinic. We 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 we would like to know which one works better. To be in this study you 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.

Official Title

Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial

Details

Dilation and Curettage (D&C) is often performed in the first trimester for surgical abortion and management of miscarriage and can be painful for patients before and after the procedure. Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control. At UCSD and UCLA, some providers routinely use a 20cc of 1% buffered lidocaine block and some routinely use a 40cc of 0.5% buffered lidocaine block. This practice has not been studied in a randomized controlled trial. The purpose of this study is to compare pain control during D&C with a 20cc 1% buffered lidocaine with vasopressin paracervical block compared to a 40cc 0.5% buffered lidocaine with vasopressin paracervical block.

An inclusion criterion for this study is that patients must specifically be referred to family planning clinics at UCSD and UCLA for an in-clinic D&C. Therefore, the D&C is a required procedure for both study groups. The only difference in care between the study groups will be which paracervical block they receive.

Keywords

Abortion Early Abortion, Missed Abortion, Spontaneous Abortion in First Trimester Lidocaine Vasopressins Arginine Vasopressin 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block 20cc 1% lidocaine with 2 units of vasopressin paracervical block

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Women over the age of 18 presenting to UC San Diego and UC Los Angeles
  2. Undesired pregnancy or missed abortion < 11 weeks 6 days gestation
  3. Must speak English or Spanish
  4. Desire surgical termination of pregnancy or management of miscarriage in clinic

You CAN'T join if...

  1. Women with a diagnosis of inevitable or incomplete abortion
  2. Desire for general anesthesia or IV sedation
  3. Chronic pain conditions
  4. Any medical comorbidities that are a contraindication to performing the procedure in the clinic setting
  5. Allergy to or refusal of ketorolac, oral Versed, or a paracervical block
  6. If they have taken any pain medications the day of presentation to clinic
  7. If they have taken Misoprostol the day of presentation to clinic

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03736681
Phase
Phase 1
Study Type
Interventional
Last Updated