Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial (SALSA)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Unwanted
• Intervention / Treatment: Drug: vaginal 2% Xylocaine; Drug: standard lidocaine paracervical block

Detailed Description

Abortion remains one of the most common surgical procedures in the world, regardless of region or development status [Guttmacher 2012]. In the United States, at least half of all women will experience an unintended pregnancy by age 45, and one third of all women will have had an abortion by this same age [Guttmacher 2014].

Despite universal efforts to increase the comfort of these procedures, pain remains a limiting factor in where and how abortion is performed. Recent estimates reveal that 70-97% of women experience pain during abortion [Renner 2010, Paul 2009, Belanger 1988]. Strategies to reduce all aspects of abortion related pain have the potential for significant public health impact, given the large number of women who seek these services. A survey of National Abortion Federation clinics found that to date, most providers (84%) employ the use of a lidocaine paracervical block for cervical anesthesia prior to abortion [O'Connell 2009], but traditionally without a waiting period between lidocaine administration and procedure initiation.

To the best of our knowledge, there are no published studies that 1) rigorously examine the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explore whether adequate pain relief is possible through self-administered, non-invasive means alone. The investigators propose to explore the effect of a locally applied lidocaine gel in place of the traditional paracervical block to decrease abortion related pain.

The objective of this study is to compare pain control at various time points during first trimester surgical abortion using a locally applied, patient-administered lidocaine gel as compared to traditional lidocaine paracervical block.

If a patient-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures, and perhaps replace paracervical injection altogether.

Hypothesis: Patients who receive lidocaine gel applied 30 minutes prior to first trimester surgical abortion will have pain control equivalent to that of a traditional paracervical block.

This is a non-inferiority, open-label, randomized controlled trial of women ages 18 and older undergoing first trimester surgical abortion at 50/7 to 116/7 weeks.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States
      • Planned Parenthood Mar Monte

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

• Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age
• Use of IV sedation for pain management
• English or Spanish speaking
• Ability to give informed consent

Exclusion criteria:

• Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)
• Allergy to study medications: lidocaine, midazolam, fentanyl
• Known uterine anomaly
• Prior cervical surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator; Drug: vaginal 2% Xylocaine	Drug: vaginal 2% Xylocaine; patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block
Other: standard lidocaine paracervical block	Drug: standard lidocaine paracervical block; 1% lidocaine paracervical injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale	This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.	At time of cervical dilation, 30 minutes after lidocaine administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale	This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.	Pain level prior to procedure
Pain With Speculum Insertion as Measured by a Visual Analog Scale	This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.	Pain at time of speculum insertion
Pain With Tenaculum Placement as Measured by a Visual Analog Scale	This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.	Pain at time of tenaculum placement
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale	This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.	Pain prior to discharge home: 30-45 minutes after completion of procedure
Overall Satisfaction With Procedure as Measured by a Visual Analog Scale	This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.	30-45 minutes after completion of procedure
Overall Complication Rate as Measured by a Count of Participants in Each Group		Rate of complications at the end of the study

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Conti JA, Lerma K, Shaw KA, Blumenthal PD. Self-Administered Lidocaine Gel for Pain Control With First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):297-303. doi: 10.1097/AOG.0000000000001532. Erratum In: Obstet Gynecol. 2016 Dec;128(6):1450.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimated): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 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; pain management
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Vaginal Lidocaine