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

• ClinicalTrials.gov Identifier: NCT02447029
• Recruitment Status: Completed
• First Posted: May 18, 2015
• Results First Posted: July 24, 2017
• Last Update Posted: July 24, 2017
• Sponsor: Stanford University
• Information provided by (Responsible Party): Jennifer Conti, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy, Unwanted	Drug: vaginal 2% Xylocaine; Drug: standard lidocaine paracervical block	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
• Study Start Date: April 2015
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

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
standard lidocaine paracervical block; standard lidocaine paracervical block	Drug: standard lidocaine paracervical block; 1% lidocaine paracervical injection

Outcome Measures

Primary Outcome Measures :

1. Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale [ Time Frame: At time of cervical dilation, 30 minutes after lidocaine administration ]
   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.

Secondary Outcome Measures :

1. Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale [ Time Frame: Pain level prior to procedure ]
   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.
2. Pain With Speculum Insertion as Measured by a Visual Analog Scale [ Time Frame: Pain at time of speculum insertion ]
   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.
3. Pain With Tenaculum Placement as Measured by a Visual Analog Scale [ Time Frame: Pain at time of tenaculum placement ]
   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.
4. Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale [ Time Frame: Pain prior to discharge home: 30-45 minutes after completion of procedure ]
   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.
5. Overall Satisfaction With Procedure as Measured by a Visual Analog Scale [ Time Frame: 30-45 minutes after completion of procedure ]
   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.
6. Overall Complication Rate as Measured by a Count of Participants in Each Group [ Time Frame: Rate of complications at the end of the study ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Planned Parenthood Mar Monte

San Jose, California, United States

Sponsors and Collaborators

Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jennifer Conti, Principle investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02447029
• Other Study ID Numbers: Vaginal Lidocaine
• First Posted: May 18, 2015
• Results First Posted: July 24, 2017
• Last Update Posted: July 24, 2017
• Last Verified: July 2017

Keywords provided by Jennifer Conti, Stanford University:

abortion; pain management

Additional relevant MeSH terms:

Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action