Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o

March 28, 2023 updated by: Sheila Mody, University of California, San Diego

Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Villa La Jolla Clinic
      • San Diego, California, United States, 92103
        • UCSD Medical Offices South

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
Other Names:
  • 40cc
Active Comparator: 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
Drug: 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.
Other Names:
  • 20cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain With Cervical Dilation
Time Frame: 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.
Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain With Uterine Aspiration
Time Frame: 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.
Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.
Pain 10 Minutes Post Procedure
Time Frame: 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.
Once 10 minutes after the procedure on the day of recruitment, approximately one minute.
Overall Pain
Time Frame: 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.
Once 10 minutes after the procedure on the day of recruitment, approximately one minute.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of California, Los Angeles
Society of Family Planning

Investigators

  • Principal Investigator: Sheila K Mody, MD MPH, UCSD Department of Ob/Gyn and Reproductive Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180999.o

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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