Abortion Early, Abortion in First Trimester, Abortion, Missed, Abortion, Spontaneous, Pain Uterus
Conditions
Keywords
Dilation & curettage, Paracervical block
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.
Interventions
DRUG40cc 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.
DRUG20cc 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.
Sponsors
Society of Family Planning
University of California, Los Angeles
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 57 |
| 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
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. | 57 |
| Total | 114 |
Baseline characteristics
| Characteristic | 40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block | 20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 57 Participants | 114 Participants |
| Age, Continuous | 31.9 years STANDARD_DEVIATION 7.1 | 31.5 years STANDARD_DEVIATION 6.6 | 31.7 years STANDARD_DEVIATION 6.8 |
| Induced Abortion vs Early Pregnancy Loss D&C for Early Pregnancy Loss | 29 Participants | 29 Participants | 58 Participants |
| Induced Abortion vs Early Pregnancy Loss D&C for Induced Abortion | 28 Participants | 28 Participants | 56 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latina | 13 Participants | 12 Participants | 25 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other or Multiracial | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 32 Participants | 60 Participants |
| Region of Enrollment United States | 57 Participants | 57 Participants | 114 Participants |
| Sex: Female, Male Female | 57 Participants | 57 Participants | 114 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 15 / 57 | 12 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
Pain With 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.
Time frame: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
Population: Data missing for one participant in the 20cc group because cervical dilation was not performed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain With Cervical Dilation | 52 units on a scale |
| 40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain With Cervical Dilation | 45 units on a scale |
Secondary
Overall Pain
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.
Time frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block | Overall Pain | 57 units on a scale |
| 40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block | Overall Pain | 56 units on a scale |
Secondary
Pain 10 Minutes Post Procedure
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.
Time frame: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain 10 Minutes Post Procedure | 26 units on a scale |
| 40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain 10 Minutes Post Procedure | 11 units on a scale |
Secondary
Pain With 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.
Time frame: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
Population: Data missing for one participant in the 20cc group because aspiration unable to be performed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain With Uterine Aspiration | 46 units on a scale |
| 40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block | Pain With Uterine Aspiration | 58 units on a scale |