Clinical trial NCT03356145: 12 Versus 20 mL PCB for D&E Cervical Prep
Official title: 12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: paracervical block
abortion
dilation and evacuation
cervical preparation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Immediately Following Dilator Insertion
timeFrame: Time of dilator insertion (less than 1 minute to assess pain)
Secondary outcomes:
measure: Anticipated Pain Immediately Prior to Dilator Insertion
timeFrame: Up to 1 minute to complete survey
measure: Patient Global Satisfaction Score
timeFrame: Up to 1 minute to complete survey
measure: Total Procedure Time
timeFrame: Up to 10 minutes
measure: Physician-reported Ease of Insertion
timeFrame: Up to 1 minute to complete survey
measure: Count of Participants With Procedural Complications
timeFrame: Up to 10 minutes
measure: Count of Participants With Side Effects Related to Lidocaine Administration
timeFrame: Up to 10 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: 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.