Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Buffered Lidocaine in Paracervical Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03107754
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Drug: Lidocaine-Sodium Bicarbonate Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

A statistician not involved with the conduct of the study will use a computer random number generator to generate random permuted blocks. This statistician will place allocation assignment cards in sequentially numbered, sealed, opaque envelopes. A different randomization scheme will be used for each location, one at the Kapi'olani office and one at the Queen's office.

A clinic staff member not involved with the conduct of the study will be trained specifically in the opening of the allocation envelopes. The staff member will be trained to open the envelope and remove the study card to read the allocation group: buffered lidocaine or plain lidocaine. The clinic staff member will then prepare the buffered lidocaine or plain lidocaine in an unlabeled syringe, and place it on the surgical tray.

Primary Purpose: Treatment
Official Title: Buffered Lidocaine for Paracervical Block to Decrease Injection Pain During First Trimester Uterine Aspirations
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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 4 points at the cervicovaginal junction to decrease pain
Other Name: 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 4 points at the cervicovaginal junction to decrease pain




Primary Outcome Measures :
  1. Injection pain [ Time Frame: Immediately after injection of the paracervical block ]
    Compare pain scores on a 100 mm VAS (anchors 0=no pain; 100=worst pain ever)


Secondary Outcome Measures :
  1. Pain after speculum placement, cervical dilation, aspiration, and immediately post-operatively [ Time Frame: Immediately after speculum placement, cervical dilation, uterine aspiration, and immediately after the procedure ]
    Compare pain scores on a 100 mm VAS (anchors 0=no pain; 100=worst pain ever)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 [LMP] 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

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): NCT03107754


Contacts
Layout table for location contacts
Contact: Principal Investigator (808) 203-6500 WHRC@hawaii.edu

Locations
Layout table for location information
United States, Hawaii
Womens Options Center Recruiting
Honolulu, Hawaii, United States, 96814
Contact: Principal Investigator       whrc@hawaii.edu   
Sponsors and Collaborators
University of Hawaii
Investigators
Layout table for investigator information
Principal Investigator: Principal Investigator University of Hawaii

Publications:

Layout table for additonal information
Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03107754     History of Changes
Other Study ID Numbers: 2017-00083
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
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