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Paracervical Block Volume and Pain Control During Dilation and Curettage

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ClinicalTrials.gov Identifier: NCT03636451
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Bonnie Crouthamel, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Abortion, Spontaneous Abortion in First Trimester Pain Uterus Drug: 0.5% Lidocaine Drug: 1% Lidocaine Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636451


Contacts
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Contact: Research Assistant 8583294464 familyplanningresearch@ucsd.edu

Locations
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United States, California
Villa La Jolla Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Gennifer Kulley, MPH         
UCSD Medical Offices South Recruiting
San Diego, California, United States, 92103
Contact: Gennifer Kulley, MPH         
Sponsors and Collaborators
University of California, San Diego
Society of Family Planning
Investigators
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Principal Investigator: Bonnie Crouthamel Physician

Additional Information:
Publications:

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Responsible Party: Bonnie Crouthamel, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03636451     History of Changes
Other Study ID Numbers: PCB40v20
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Bonnie Crouthamel, University of California, San Diego:
Dilation & curettage
Paracervical block
Additional relevant MeSH terms:
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Abortion, Spontaneous
Dilatation, Pathologic
Pathological Conditions, Anatomical
Pregnancy Complications
Lidocaine
Vasopressins
Arginine Vasopressin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents