Clinical trial NCT03636451
Conditions: Abortion, Spontaneous Abortion in First Trimester Pain Uterus Abortion Early Abortion, Missed
Keywords: Dilation & curettage Paracervical block
Sponsor: University of California, San Diego
Start date: 2018-10-29; Completion date: 2022-09-27
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation arm 2: 20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
Interventions: intervention 1: 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block intervention 2: 20cc 1% lidocaine with 2 units of vasopressin paracervical block
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o 
 
 
NCT #03636451 
 
Document Date February 28, 2022 
 


 
Protocol: 
We conducted a multi-site, randomized single-blinded clinical trial comparing pain control at the time of 
cervical dilation with two different paracervical blocks in patients undergoing D&C in the first trimester 
for either induced abortion or early pregnany loss (EPL) management. The study took place from October 
2018 to December 2020 at the University of California, San Diego (UCSD) and the University of 
California, Los Angeles (UCLA). The institutional review board of the University of California, Los 
Angeles approved the protocol and relied on the IRB approval of the University of California, San Diego. 
Consort guidelines were used for reporting. 
 
After performing a history, physical examination, and ultrasound if indicated, and completing informed 
consent for clinic D&C under minimal sedation, participants were recruited by a separate study team 
member. Written informed consent for the study was then obtained. We included participants ages 18 
years and older presenting to UCSD or UCLA outpatient family planning clinics with an undesired 
pregnancy or early pregnancy loss measuring <11 weeks 6 days gestation on ultrasound, who speak 
English or Spanish and desire to have a clinic D&C. We excluded patients with pregnancy of unknown 
location, inevitable or incomplete abortion (defined as absence of a gestational sac on ultrasound and/or 
open cervical os), desire for general anesthesia or IV sedation, history of chronic pain conditions, and 
history of any medical comorbidities that are a contraindication to performing the procedure in the clinic 
setting. We also excluded patients if they declined or had an allergy to ketorolac, oral midazolam, or any 
component of the paracervical block or if they took any pain medication or misoprostol the day of the 
procedure. 
 
Before the procedure, the study team member enrolling the participants performed a baseline survey 
detailing the participant’s age, race, ethnicity, obstetric history, history of cervical procedures, baseline 
pain using the 100mm VAS and the GAD-7, a validated measure of anxiety.14 The participant then 
received 60mg IM ketorolac, 10mg oral midazolam, and 500mg PO azithromycin 30-35 minutes prior to 
the procedure perstandard practice at the UCSD clinic. 
 
Randomization was stratified by site and was performed using 85 blocks of 4 and 6 which were varied 
randomly. A statistician not involved in enrollment prepared sequential, sealed, numbered, opaque 
envelopes containing a card with computer-generated assignment. The envelopes were chosen in 
consecutive order by research assistants at the time of randomization, and the participant’s initials were 
written on the envelope. The physician performing the procedure (which consisted of residents, fellows, 
and attendings) then opened the envelope and prepared 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 low volume block contained 20mL of 1% lidocaine (diluted in saline), and the high-volume 
paracervical block contained 40mL of 0.5% lidocaine (diluted in saline). The paracervical block in both 
arms contained 2U Vasopressin and 2mL of 8.4% sodium bicarbonate. The contents of each paracervical 
block were drawn from their respective vials, mixed in a sterile cup, and drawn into 2 separate 20mL 
syringes (10mL in each syringe for the lower volume block). The physician brought the paracervical 
block on a covered tray into the clinic room where the procedure was performed and the study participant 
and team member assessing the outcomes were blinded to study group. The block technique was 
standardized. Before placement of the tenaculum, 2mL of the designated block was injected on the 
anterior lip of the cervix. The remainder of the block (either 18 mL or 38 mL depending on the group) 
was then injected paracervically at four points around the cervix at the cervico-vaginal junction, initially 
injecting half of the block superficially and advancing to a depth of three centimeters and injecting the 
remaining block, which is consistent with prior literature.5,15,16 The duration of the injection was timed. 
We waited 3 minutes between completing the injection and starting the cervical dilation. The procedures 
were performed with manual uterine aspiration (MUA). To better standardize the impact of any verbal 


interaction on pain during the procedure, the physician performing the suction D&C was given a standard 
script to inform the patient of each next step. A member of the study team, who was blinded to the type of 
paracervical block, presented the VAS to the participant and asked the participant to mark level of pain at 
baseline, speculum insertion, paracervical block placement, cervical dilation, immediately after uterine 
aspiration, 10 minutes after the procedure, and overall pain. Additionally, after paracervical block 
placement, the participant was asked about side effects. The study coordinator recorded the duration of 
the procedure. 
After the procedure, the clinician answered a brief questionnaire detailing any adverse events or 
challenges related to either the paracervical block or the D&C. The clinician also noted how much 
cervical dilation was performed, the size of the suction cannula used for uterine aspiration, 113 if a repeat 
aspiration was needed for an incomplete D&C after examination of the products of conception, if an 
intrauterine device (IUD) was placed and their level of training. The participant indicated overall pain and 
answered questions about satisfaction with pain control. 
 
Statistical Analysis Plan: 
The primary outcome was difference in median pain scores on the VAS during cervical dilation. The 
secondary outcomes were differences in median pain scores at block placement, uterine aspiration, 10 
minutes after the procedure, overall pain, and side effects. Analyses were performed among each study 
strata (induced abortion and EPL) and in the overall cohort. Bivariate comparisons were analyzed using 
chi-squared tests or Fischer’s exact tests for categorical variables and t-tests or Wilcoxon rank-sum tests 
for continuous variables as appropriate. The primary outcome (pain score at time of cervical dilation) was 
evaluated per intent-to-treat analysis. Rates of minor side effects (transient lightheadedness, tinnitus, 
circumoral tingling, and a metallic taste in the mouth) and major adverse events (seizure and 
cardiopulmonary arrest) were recorded. 
We performed univariate and multivariate analyses for each potential confounder with the outcome of 
interest to determine which predictors to include in the multivariable analysis for each pain point and 
included covariates associated with a p-value of <0.20. All analyses were performed using RStudio 
(2021). 
Prior literature suggests that a 13-mm to 20mm difference in pain is clinically meaningful. Similar 
studies of paracervical blocks during D&C procedures have found a standard deviation in the VAS of 
26mm, which was used to calculate the effect size.15,16. We estimated that to detect a more subtle 15mm 
or greater difference in pain at the time of cervical dilation with 80% power and a two-sided alpha of 
0.05, a total of 104 participants was required. Therefore, the study was powered to detect a 15mm 
difference in pain control in the overall cohort. This allowed for the power to detect a 20mm or greater 
difference in pain at the time of cervical dilation within each strata (induced abortion and EPL). 
 

ICF_001.pdf: 
UCSD Human Research Protection Program 
(858) 246-HRPP (858-246-4777) 
UCSD Study #180999 
Page 1 of 5 
 
Version 9/30/13 
 
University of California, San Diego 
Consent to Act as a Research Subject 
 
Higher volume paracervical block for pain control in dilation and curettage:  
a randomized controlled trial 
 
Who is conducting the study, why have you been asked to participate, how were you selected, 
and what is the approximate number of participants in the study? 
Dr. Mody and research team at UCSD are conducting a research study in collaboration with Dr. 
Rible, Dr. Taylor and research team from UCLA to find out more about pain control with 
dilation and curettage (D&C). You have been asked to participate in this study because you are 
going to receive a D&C today. There will be approximately 120 participants at all sites. 
 
Why is this study being done? 
The purpose of this study is to determine if different volumes of liquid in a paracervical block 
can improve pain control. A paracervical block is placing lidocaine near the cervix to stop pain 
in the nerve fibers.  The higher volume paracervical block contains more saline but the same 
amount of lidocaine than the lower volume paracervical block.  Both paracervical blocks are 
currently used in practice in this clinic, and lidocaine is FDA approved to provide local 
anesthesia. 
 
What will happen to you in this study and which procedures are standard of care and which 
are experimental? 
If you agree to be in this study, the following will happen to you: 
1. The risks and benefits of participation will be explained to you and you will be asked to 
sign this consent form.  
2. Before the procedure begins, you will be asked to complete a brief survey and indicate 
your level of baseline pain on a visual analogue scale.  You will then receive an injection 
of Toradol and oral Versed. 
3. During the procedure, you will receive a paracervical block, which happens during all 
D&C procedures. A paracervical block is placing lidocaine near the cervix to stop pain in 
the nerve fibers.  The higher volume paracervical block contains more saline but the same 
amount of lidocaine than the lower volume paracervical block.  Both paracervical blocks 
are currently used in practice in this clinic, but the lower volume block is used more 
widely throughout the country.  You will not be told which paracervical block you have 
received.  You will be assigned by chance to a study group. Your chance of being 
assigned to each group is 1 in 2. Neither you nor the researcher(s) can choose the group 
to which you will be assigned.  
4. Your clinician will perform the D&C in the usual fashion. During the procedure you will 
be asked to mark your pain level on a visual analogue scale for speculum (the instrument 
that goes in the vagina to help see the cervix) insertion, paracervical block placement, 
cervical dilation, and when the uterus is being emptied. At the time of paracervical block 
placement, you will also be asked about side effects you may have experienced from the 
injection. 
Human Research 
Protections Program 
 
 
 
Approved 
    Current Approval: 
09/25/2020 
      Do not use after 
10/03/2021 
 
 Pages 5 


UCSD Human Research Protection Program 
 (858) 246-HRPP (858-246-4777) 
UCSD Study #180999 
 
Page 2 of 5 
 
Version 9/30/13 
Human Research 
Protections Program 
 
 
 
Approved 
   Current Approval: 
09/25/2020 
   Do not use after 
10/03/2021 
 
5. At the completion of the procedure, you will be asked to assess your pain on a visual 
analogue scale at 10 minutes after the procedure and overall pain. You will also be given 
a brief survey. 
6. Afterwards, you can take acetaminophen or ibuprofen as needed for any additional pain. 
  
This will conclude your participation in the study. No further follow-up is needed.  
 
How much time will each study procedure take, what is your total time commitment, and how 
long will the study last? 
After you consent to participate, the total amount of time for pre-medication, D&C procedure, 
paracervical block placement, and follow up survey will take approximately 1 hour. 
 
What risks are associated with this study? 
Participation in this study may involve some added risks or discomforts. These include the 
following:  
 
You will be assigned to a study group at random (by chance). Your assignment is based on 
chance rather than a medical decision made by the researchers. The study group to which you are 
assigned might not be the group you would prefer. Your assigned study group might also prove 
to be less effective or have more side effects than the other study group, or other treatments 
available for your condition. 
 
With either paracervical block, moderate discomfort with the injection is a common and 
expected known side effect. Some other relatively common side effects include dizziness, 
ringing in the ears, palpitations, tingling around the mouth, and a metallic taste in the mouth.  
These side effects are mild and usually last for a short duration. A few cases of serious heart 
problems or death have ever been reported. 
 
Because this is a research study, there may be some unknown risks that are currently 
unforeseeable. You will be informed of any significant new findings. 
 
What are the alternatives to participating in this study? 
The alternatives to participation in this study are not to participate. Participation in this research 
project is entirely voluntary. You may refuse to participate or withdraw at any time without 
jeopardy to the medical care you will receive at this institution. 
 
What benefits can be reasonably expected? 
There may or may not be any direct benefit to you from these procedures. The investigators, 
however, may learn more about pain control during D&C procedures which may help women 
receiving D&Cs in the future. 
 
Can you choose to not participate or withdraw from the study without penalty or loss of 
benefits? 
Participation in research is entirely voluntary. You may refuse to participate or you may 
withdraw at any time without penalty or loss of benefits to which you are entitled.  


UCSD Human Research Protection Program 
 (858) 246-HRPP (858-246-4777) 
UCSD Study #180999 
 
Page 3 of 5 
 
Version 9/30/13 
Human Research 
Protections Program 
 
 
 
Approved 
   Current Approval: 
09/25/2020 
   Do not use after 
10/03/2021 
 
Can you be withdrawn from the study without your consent? 
You may be withdrawn from the study if you do not follow the instructions given you by the 
study personnel. 
 
Will you be compensated for participating in this study? 
In compensation for your time, you will receive a $20 Amazon e-gift card for participating in 
this research.  You will receive this gift card by email within 24 hours after you have completed 
study participation. 
 
Are there any costs associated with participating in this study? 
There will be no cost to you for participating in this study.  The paracervical block will be 
supplied at no cost while you take part in this study. You and/or your health plan/insurance 
company will need to pay for all of the other costs related to the D&C while in this study, per 
standard clinical care.   
 
What if you are injured as a direct result of being in this study? 
If you are injured as a direct result of participation in this research, the University of California 
will provide any medical care you need to treat those injuries. The University will not provide 
any other form of compensation to you if you are injured. You may call the Human Research 
Protections Program Office at (858) 246-4777 for more information about this, to inquire about 
your rights as a research subject, or to report research-related problems. 
 
What about your confidentiality? 
Research records will be kept confidential to the extent allowed by law. You will be identified 
only by a unique identification number and your personal information such as name, email 
address, etc. will not be disclosed to others in order to maintain confidentiality. The data 
collected from the study will be kept on a secure computer requiring password access, and paper 
forms will be kept in a locked and secure file cabinet in the office of the research team. Research 
records may be reviewed by the UCSD Institutional Review Board and FDA. 
 
Under California law, we must report information about known or reasonably suspected 
incidents of abuse or neglect of a child, dependent adult or elder including physical, sexual, 
emotional, and financial abuse or neglect. If any investigator has or is given such information, he 
or she may be required to report such information to the appropriate authorities. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the research study results. You can search this website at any 
time. 
 
 
Who can you call if you have questions? 
Dr. Mody and/or study team members have explained this study to you and answered your 
questions. If you have other questions or research-related problems, you may call the research 
team at 858-329-4464. 


UCSD Human Research Protection Program 
 (858) 246-HRPP (858-246-4777) 
UCSD Study #180999 
 
Page 4 of 5 
 
Version 9/30/13 
Human Research 
Protections Program 
 
 
 
Approved 
   Current Approval: 
09/25/2020 
   Do not use after 
10/03/2021 
 
 
You may call the UCSD Human Research Protections Program Office at (858) 246-4777 to 
inquire about your rights as a research subject or to report research-related problems. 
 
Your Signature and Consent 
You have received a copy of this consent document and a copy of the “Experimental Subject's 
Bill of Rights´ to keep. 
 
You agree to participate. 
 
 
________________________________________________ 
_______________ 
Subject's signature 
 
 
 
 
 
 
Date 


UCSD Human Research Protection Program 
 (858) 246-HRPP (858-246-4777) 
UCSD Study #180999 
 
Page 5 of 5 
 
Version 9/30/13 
Human Research 
Protections Program 
 
 
 
Approved 
   Current Approval: 
09/25/2020 
   Do not use after 
10/03/2021 
 
SUBJECT’S BILL OF RIGHTS 
 
It is important that the purpose and procedures of the research study are fully 
understood and that consent is offered willingly. A subject in a research study or 
someone, who is asked to give consent on behalf of another person for such 
participation, has the right to the following: 
 
1. 
Be informed of the nature and purpose of the research. 
 
2. 
Be given an explanation of all procedures to be followed and of any drug or 
device to be used. 
 
3. 
Be given a description of any risks or discomforts, which can be reasonably 
expected to result from this research study. 
 
4. 
Be given an explanation of any benefits, which can be reasonably expected to 
the subject as a result of this research study. 
 
5. 
Be informed of any appropriate alternative procedures, drugs, or devices that 
may be advantageous and of their relative risks and discomforts. 
 
6. 
Be informed of any medical treatment, which will be made available to the 
subject if complications should arise from this research. 
 
7. 
Be given an opportunity and encouraged to ask any questions concerning the 
study or the procedures involved in this research. 
 
8. 
Be made aware that consent to participate in the research may be withdrawn and 
that participation may be discontinued at any time without affecting continuity or 
quality of medical care. 
 
9. 
Be given a copy of the signed and dated written consent form. 
 
10. 
Not be subjected to any element of force, fraud, deceit, duress, coercion, or any 
influence in reaching the decision to consent or to not consent to participate in 
the research. 
 
 
If \RX KaYe aQ\ fXUWKeU TXeVWLRQV RU cRQceUQV abRXW \RXU cKLOd¶V ULgKWV aV a UeVeaUcK 
subject, please contact your research doctor RU UCSD¶V HXPaQ ReVeaUcK PURWecWLRQV 
Program at 858-246-HRPP (858-246-4777).