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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
Injection of 12 mL of lidocaine
Injection of 20 mL of lidocaine
Stanford University
Stanford, California, United States
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 frame: Time of dilator insertion (less than 1 minute to assess pain)
Anticipated Pain Immediately Prior to Dilator Insertion
Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Time frame: 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").
Time frame: Up to 1 minute to complete survey
Total Procedure Time
Defined as time of speculum insertion
Time frame: Up to 10 minutes
Physician-reported Ease of Insertion
Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").
Time frame: Up to 1 minute to complete survey
Count of Participants With Procedural Complications
Time frame: 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.
Time frame: Up to 10 minutes
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