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

NCT02447029 | Completed Phase 3 Results

• 1 other identifier: Vaginal Lidocaine
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, Unwanted

Keywords

abortion; pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale

  Pain level prior to procedure

• Pain With Speculum Insertion as Measured by a Visual Analog Scale

  Pain at time of speculum insertion

• Pain With Tenaculum Placement as Measured by a Visual Analog Scale

  Pain at time of tenaculum placement

• Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale

  Pain prior to discharge home: 30-45 minutes after completion of procedure

• Overall Satisfaction With Procedure as Measured by a Visual Analog Scale

  30-45 minutes after completion of procedure

Study Arms (2)

Active Comparator

EXPERIMENTAL

Drug: vaginal 2% Xylocaine

Drug: vaginal 2% Xylocaine

standard lidocaine paracervical block

OTHER

standard lidocaine paracervical block

Drug: standard lidocaine paracervical block

Interventions

vaginal 2% Xylocaine DRUG

patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block

Active Comparator

standard lidocaine paracervical block DRUG

1% lidocaine paracervical injection

standard lidocaine paracervical block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Planned Parenthood Mar Monte

San Jose, California, United States

Location

Related Publications (1)

• 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.

  PMID: 27400015 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

650-497-5175

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: May 18, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 14, 2024
• Results First Posted: July 24, 2017

Record last verified: 2024-01

Locations

US (1)