12 Versus 20 mL PCB for D&E Cervical Prep

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: 12 mL paracervical block; Drug: 20 mL paracervical block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12 mL arm; Intervention: Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle; 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix; The tenaculum is immediately placed at the previously injected site; The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal); No wait time between injection and dilator insertion	Drug: 12 mL paracervical block; Injection of 12 mL of lidocaine
Active Comparator: 20 mL arm; Intervention: Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle; 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix; The tenaculum is immediately placed at the previously injected site; The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal); No wait time between injection and dilator insertion	Drug: 20 mL paracervical block; Injection of 20 mL of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Total Procedure Time	Defined as time of speculum insertion	Up to 10 minutes
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
Count of Participants With Procedural Complications		Up to 10 minutes
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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Shaw KA, Lerma K, Hughes T, Hastings C, Fok WK, Blumenthal PD. A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: abortion; paracervical block; dilation and evacuation; cervical preparation
• Other Study ID Numbers: IRB-43789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

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.: No