12 Versus 20 mL PCB for D&E Cervical Prep

Phase 4

Completed

Interventions: Drug: 12 mL paracervical block
Drug: 20 mL paracervical block

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
12 mL arm	12 mL paracervical block	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
20 mL arm	20 mL paracervical block	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

Primary Outcome Measures

Name	Time	Method
Pain Immediately Following Dilator Insertion	Time of dilator insertion (less than 1 minute to assess pain)	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).

Secondary Outcome Measures

Name	Time	Method
Anticipated Pain Immediately Prior to Dilator Insertion	Up to 1 minute to complete survey	Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Patient Global Satisfaction Score	Up to 1 minute to complete survey	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").
Total Procedure Time	Up to 10 minutes	Defined as time of speculum insertion
Physician-reported Ease of Insertion	Up to 1 minute to complete survey	Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").
Count of Participants With Side Effects Related to Lidocaine Administration	Up to 10 minutes	Side effects were not necessarily considered to be adverse events by investigator.
Count of Participants With Procedural Complications	Up to 10 minutes