12 Versus 20 mL PCB for D&E Cervical Prep

Pain Clinical Trial

Official title:

12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356145
• Other study ID #: IRB-43789
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.

Description:

This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 and older
• Intrauterine pregnancy =16 weeks gestation
• English speaking competency
• Willing and able to sign consent forms
• Agree to comply with study procedures

Exclusion Criteria:

• Women less than 18 years of age
• IV conscious sedation
• Known allergy to study medication (lidocaine)
• Any women not meeting inclusion criteria above will be excluded from participation

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 12 mL paracervical block
Injection of 12 mL of lidocaine
• 20 mL paracervical block
Injection of 20 mL of lidocaine

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Immediately Following Dilator Insertion	The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).	Time of dilator insertion (less than 1 minute to assess pain)
Secondary	Anticipated Pain Immediately Prior to Dilator Insertion	Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).	Up to 1 minute to complete survey
Secondary	Patient Global Satisfaction Score	Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").	Up to 1 minute to complete survey
Secondary	Total Procedure Time	Defined as time of speculum insertion	Up to 10 minutes
Secondary	Physician-reported Ease of Insertion	Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").	Up to 1 minute to complete survey
Secondary	Count of Participants With Procedural Complications		Up to 10 minutes
Secondary	Count of Participants With Side Effects Related to Lidocaine Administration	Side effects were not necessarily considered to be adverse events by investigator.	Up to 10 minutes