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

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Abortion, Missed; Pain Uterus; Abortion, Spontaneous; Abortion in First Trimester; Abortion Early

Treatments: Drug: 20cc 1% lidocaine with 2 units of vasopressin paracervical block; Drug: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT03636451

180999.o

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

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

Experimental group

Description:

40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation

Treatment:

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

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

Active Comparator group

Description:

20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation

Treatment:

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