Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Condition: Abortion, Spontaneous; Abortion in First Trimester; Pain Uterus; Abortion Early; Abortion, Missed
MeSH terms: Abortion, Spontaneous; Abortion, Missed; Dilatation, Pathologic
Intervention: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block; 20cc 1% lidocaine with 2 units of vasopressin paracervical block
Intervention description: 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.; 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.
Intervention MeSH terms: Lidocaine; Vasopressins; Arginine Vasopressin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking description: The study coordinator, who will be blinded to the intervention, will pick the designated sealed, opaque envelope containing the type of paracervical block and hand it to the physician performing the procedure. The physician will then open the envelope and prepare the designated paracervical block, as it is standard practice for physicians to prepare their own paracervical blocks prior to performing any D&C in-clinic. The paracervical block will contain 2U Vasopressin, 2cc of 8.4% sodium bicarbonate, and either 1% lidocaine or 0.5% lidocaine, depending on the study group. The physician will bring the paracervical block into the clinic room where the procedure will be performed on a covered tray. The physician will perform the standardized procedure for the D&C, and the study coordinator will assess pain control during the procedure.
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dilation & curettage; Paracervical block

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.
    

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