Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/11/2018 |
| Start Date: | October 29, 2018 |
| End Date: | August 30, 2019 |
| Contact: | Marisa Hildebrand, MPH |
| Email: | familyplanningresearch@ucsd.edu |
| Phone: | 858-329-4464 |
Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
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.
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.
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.
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.
Inclusion Criteria:
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
Exclusion criteria:
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
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Bonnie Crouthamel, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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