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

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736681
• Other study ID #: 180999
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 29, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: July 1, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women over the age of 18 presenting to University of California, San Diego (UCSD) and University of California, Los Angeles (UCLA)

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

Related Conditions & MeSH terms

• Abortion Early
• Abortion in First Trimester
• Abortion, Missed
• Abortion, Spontaneous

Intervention

Drug:
• 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
• 20cc 1% lidocaine with 2 units of vasopressin paracervical block
Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during cervical dilation	Distance (mm) from the left of the 100-mm Visual Analogue Scale (VAS) scale (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. We will also assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step.	immediate
Secondary	Pain level at other time points (baseline, speculum placement, block placement, uterine aspiration, 10 minutes post-procedure, overall)	pain at different time points	during 1 day of clinic visit
Secondary	Patient Satisfaction	How did the paint compare to the expected pain? What could have been better?	during 1 day of clinic visit
Secondary	Adverse events	side effects at time of paracervical block placement	immediate
Secondary	Survey of provider performing procedure	Clinical questions about the patient and the procedure	during 1 day of clinic visit