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Paracervical Block Volume and Pain Control During Dilation and Curettage

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ClinicalTrials.gov Identifier: NCT03636451
Recruitment Status : Unknown
Verified July 2019 by Bonnie Crouthamel, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : August 17, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Bonnie Crouthamel, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Pain with cervical dilation [ Time Frame: Once during the procedure on the day of recruitment ]
Distance (mm) from the left of the 100-mm 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Pain with uterine aspiration [ Time Frame: Once during the procedure on the day of recruitment ]
    Distance (mm) from the left of the 100-mm VAS scale (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 [ Time Frame: Once 10 minutes after the procedure on the day of recruitment ]
    Distance (mm) from the left of the 100-mm VAS scale (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 [ Time Frame: Once 10 minutes after the procedure on the day of recruitment ]
    Distance (mm) from the left of the 100-mm VAS scale (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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paracervical Block Volume and Pain Control During Dilation and Curettage
Official Title  ICMJE Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Brief Summary 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 cervix1-10. A paracervical block with 20cc of 1% buffered lidocaine has been proven to provide superior pain control than a sham paracervical block13. However, many providers often use similar doses of lidocaine in a higher volume to improve pain control4-5. At UCSD and 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.
Detailed Description

OVERVIEW OF DESIGN 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.

Primary Hypothesis:

In patients undergoing first trimester D&C with minimal sedation, a 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block will improve pain control by 20-mm on a 100-mm visual analog scale (VAS) compared to a 20cc 1% lidocaine with 2 units of vasopressin paracervical block at the time of cervical dilation.

Secondary hypotheses:

In patients undergoing first trimester dilation and curettage (D&C), a 40cc buffered 0.5% lidocaine with 2 units vasopressin paracervical block compared to a 20cc 1% lidocaine with 2 units vasopressin paracervical block will improve pain control by 20-mm on a 100-mm VAS at the time of paracervical block placement, uterine aspiration and 10 minutes after the procedure.

In order to investigate this hypothesis, the following study design is proposed:

The study will take place in the family planning clinics at UCSD and UCLA. At UCSD and UCLA, family planning clinics help guide patients in the management of their miscarriages and undesired pregnancies. Any clinician can refer patients to this clinic and appointments are coordinated by a Family Planning Coordinator. During this study, upon presentation to clinical care for termination of pregnancy or miscarriage, the clinician will take a full history, perform a physical exam, and counsel the patient about her options including using medications, performing a D&C in clinic, and performing a D&C under anesthesia in the operating room, all of which is standard for a clinic visit in the family planning clinics. If the patient desires a clinic-based D&C, a dating ultrasound will be performed, and the clinician will assess for medical contraindications to clinic D&C or chronic pain conditions, as is standardly done for every D&C in the family planning clinics. If she is eligible for D&C, informed consent will be obtained for the procedure, per standard clinic practice. The study coordinator will then assess if the patient is interested in participating in the study, ensure that the patient is willing to take the study medications and that she has not taken any pain medications that day. The study coordinator will then obtain written informed consent to participate and perform the baseline survey detailing her age, race, ethnicity, level of education, income level, height, weight, obstetric history, history of cervical procedures (eg LEEP procedure or Conization), current pregnancy status (undesired pregnancy vs. early pregnancy loss), baseline anxiety using the GAD-7 (a validated tool used to assess for anxiety in primary care settings18). The patient will then receive 60mg IM ketorolac, 10mg oral Versed, and 500mg oral Azithromycin 30 minutes prior to the procedure per usual clinic protocol.

Block randomization will be performed (alternating block sizes of 4 and 6). The study coordinator 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.

The study coordinator, who will be blinded to the type of paracervical block, will present the VAS to the participant ask her to mark her 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 will be asked about side effects of lightheadedness, tinnitus, circumoral tingling, and a metallic taste in the mouth. The physician will perform the D&C in the usual fashion, and the study coordinator will record the time from speculum insertion to speculum removal.

After the procedure, the physician will answer a questionnaire detailing if there were any adverse events related to either the paracervical block or the D&C, such as cardiac arrest, uterine perforation, or hemorrhage. The physician will also note the uterine position, how much cervical dilation was performed, and their level of training and prior experience with the procedure. That patient will also answer questions about satisfaction with pain control.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Abortion, Spontaneous
  • Abortion in First Trimester
  • Pain Uterus
Intervention  ICMJE
  • Drug: 0.5% Lidocaine
    Prior to cervical dilation, paracervical block will be placed one time containing Paracervical block containing 38mL of 0.5% lidocaine buffered with 2mL 8.4% sodium bicarbonate and 2 units Vasopressin
  • Drug: 1% Lidocaine
    Prior to cervical dilation, paracervical block will be placed one time containing Paracervical block containing 18mL of 1% lidocaine buffered with 2mL 8.4% sodium bicarbonate and 2 units Vasopressin
Study Arms  ICMJE
  • Experimental: 40cc 0.5% Lidocaine
    Prior to cervical dilation, paracervical block will be placed one time containing 38mL of 0.5% lidocaine buffered with 2mL 8.4% sodium bicarbonate and 2 units Vasopressin
    Intervention: Drug: 0.5% Lidocaine
  • Active Comparator: 20cc 1% Lidocaine
    Prior to cervical dilation, paracervical block will be placed one time containing 18mL of 1% lidocaine buffered with 2mL 8.4% sodium bicarbonate in and 2 units Vasopressin
    Intervention: Drug: 1% Lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03636451
Other Study ID Numbers  ICMJE PCB40v20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bonnie Crouthamel, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Bonnie Crouthamel Physician
PRS Account University of California, San Diego
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP