Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
Brief Summary: Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.

The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.

If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.


Options:
A: Arm Label: Active Comparator; Type: EXPERIMENTAL; Interventions: Drug: vaginal 2% Xylocaine | Arm Label: standard lidocaine paracervical block; Type: OTHER; Interventions: Drug: standard lidocaine paracervical block | Intervention Type: DRUG; Name: vaginal 2% Xylocaine; Assigned to Arm(s): Active Comparator | Intervention Type: DRUG; Name: standard lidocaine paracervical block; Assigned to Arm(s): standard lidocaine paracervical block
B: Intervention Type: DRUG; Name: oxycodone + lorazepam versus fentanyl + midazolam; Assigned to Arm(s): N/A
C: Arm Label: No Paracervical Block for Pain Control; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham Paracervical Block | Arm Label: Paracervical Block for Pain Control; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Paracervical Block | Intervention Type: PROCEDURE; Name: Paracervical Block; Assigned to Arm(s): Paracervical Block for Pain Control | Intervention Type: PROCEDURE; Name: Sham Paracervical Block; Assigned to Arm(s): No Paracervical Block for Pain Control
D: Arm Label: Hydrocodone/acetaminophen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydrocodone/acetaminophen, Drug: Ibuprofen, Drug: Lorazepam, Drug: Lidocaine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Ibuprofen, Drug: Lorazepam, Drug: Lidocaine | Intervention Type: DRUG; Name: Hydrocodone/acetaminophen; Assigned to Arm(s): Hydrocodone/acetaminophen | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Hydrocodone/acetaminophen, Placebo | Intervention Type: DRUG; Name: Lorazepam; Assigned to Arm(s): Hydrocodone/acetaminophen, Placebo | Intervention Type: DRUG; Name: Lidocaine; Assigned to Arm(s): Hydrocodone/acetaminophen, Placebo

Answer: A