Clinical trial NCT03636451: Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Official title: Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abortion, Spontaneous
Abortion in First Trimester
Pain Uterus
Abortion Early
Abortion, Missed
Keywords: Dilation & curettage
Paracervical block
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
name: University of California, Los Angeles
First posted: 2018-08-17
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double center, randomized, 2 arm (1:1), single blinded clinical trial comparing pain control at the time of cervical dilation with two different paracervical blocks in women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 University of California, San Diego (UCSD) and University of California, Los Angeles (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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain With Cervical Dilation
timeFrame: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
Secondary outcomes:
measure: Pain With Uterine Aspiration
timeFrame: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
measure: Pain 10 Minutes Post Procedure
timeFrame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
measure: Overall Pain
timeFrame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Villa La Jolla Clinic
state: California
city: San Diego
country: United States
facility: UCSD Medical Offices South
state: California
Study officials:
affiliation: UCSD Department of Ob/Gyn and Reproductive Sciences
name: Sheila K Mody, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Crouthamel B, Economou N, Averbach S, Rible R, Kully G, Meckstroth K, Mody SK. Effect of Paracervical Block Volume on Pain Control for Dilation and Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):234-242. doi: 10.1097/AOG.0000000000004862. Epub 2022 Jul 6.