Buffered Lidocaine in Paracervical Blocks

December 10, 2020 updated by: University of Hawaii

Buffered Lidocaine for Paracervical Block to Decrease Injection Pain During First Trimester Uterine Aspirations

For pain relief during a first trimester surgical aspiration, most providers use the paracervical block, either alone or in combination with other pain control techniques. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered versus unbuffered lidocaine for paracervical blocks during first trimester uterine aspirations. This study seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Potential participants will be identified at their office visits to the University Women's Health Specialists. If a patient desires uterine aspiration of a first trimester pregnancy or management of a failed pregnancy in the first trimester, they will first receive standard counseling. Only after providing written informed consent for the procedure will the patient's be screened for eligibility for our study. If the patient is eligible, she will be asked by a member of the research team if she is interested in participating. If she is, the study will be explained to her and written consent will be obtained after she is given the opportunity to have all of her questions answered. The patient will then complete a written questionnaire to collect demographic data.

This prospective randomized control trial will consist of two study arms. Participants will be randomly assigned to Arm 1, where a paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol, or to Arm 2, where a paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate. Prior to the start of the study, study assignments will be generated in a 1:1 ratio.

All patients who consent to the study will receive standard counseling prior to their procedure. The procedure will start with a bimanual exam by the provider. Next, the provider will place a speculum, cleanse the cervix with betadine solution, and place a single-tooth tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1 will receive a paracervical block loaded with 20 cc of 1% lidocaine and injected at 2, 4, 8 and 10 o'clock positions of the cervicovaginal junction. Participants assigned to Arm 2 will receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium bicarbonate and inject the block in the same fashion. The research assistant will ask the patient to verbally report their level of pain based on the 100 mm visual analog scale (VAS) at the following points of the procedure:

  1. Prior to the start of the procedure (baseline anxiety)
  2. After speculum placement
  3. After paracervical block
  4. After cervical dilation
  5. After suction curettage
  6. At end of procedure

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Womens Options Center

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women 14 years and older
  • Desiring uterine aspiration for pregnancy or surgical management of a miscarriage
  • Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last menstrual period or earliest ultrasound)
  • Treatment plan involves outpatient uterine aspiration
  • Participant able to provide informed consent in English and willing to participate in the study

Exclusion Criteria:

  • Unable to read, speak, or understand English
  • Unable to provide informed consent
  • Currently incarcerated
  • Under the age of 14 years
  • Contraindications to receiving lidocaine or buffered lidocaine

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard paracervical block
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Drug: Lidocaine
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Other Names:
  • Paracervical anesthesia
Experimental: Buffered lidocaine paracervical block
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Drug: Lidocaine-Sodium Bicarbonate
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Other Names:
  • Buffered paracervical anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection Pain
Time Frame: Immediately after injection of the paracervical block
For the primary outcome, pain immediately after paracervical block injection was measured by a scale. The scale used was the 100-mm visual analog scale. The minimum score was 0 and the maximum score was 100. Higher numbers indicate worse pain.
Immediately after injection of the paracervical block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain After Speculum Placement, Cervical Dilation, and Aspiration
Time Frame: Immediately after speculum placement, cervical dilation, uterine aspiration
Pain scores were measured at multiple points throughout the procedure. Pain scores were measured using a 100 mm visual analog scale with 0 being no pain and 100 being the worst pain ever.
Immediately after speculum placement, cervical dilation, uterine aspiration

Collaborators and Investigators

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

Sponsor

University of Hawaii

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

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)

May 15, 2017

Primary Completion (Actual)

October 25, 2018

Study Completion (Actual)

October 25, 2018

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00083

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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