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

Phase 3

Completed

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

Registration Number: NCT03636451

Lead Sponsor: University of California, San Diego

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block	40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block	40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block	20cc 1% lidocaine with 2 units of vasopressin paracervical block	20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation

Primary Outcome Measures

Name	Time	Method
Pain With Cervical Dilation	Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.	Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.

Secondary Outcome Measures

Name	Time	Method
Pain 10 Minutes Post Procedure	Once 10 minutes after the procedure on the day of recruitment, approximately one minute.	Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded 10 minutes after the completion of the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Pain With Uterine Aspiration	Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.	Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded immediately after uterine aspiration. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Overall Pain	Once 10 minutes after the procedure on the day of recruitment, approximately one minute.	Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded after the procedure reflecting the overall pain felt during the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.