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

NCT ID: NCT02447029

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-01-31

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.

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.

Conditions

Pregnancy, Unwanted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator

Drug: vaginal 2% Xylocaine

Group Type: EXPERIMENTAL

vaginal 2% Xylocaine

Intervention Type: DRUG

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

standard lidocaine paracervical block

standard lidocaine paracervical block

Group Type: OTHER

standard lidocaine paracervical block

Intervention Type: DRUG

1% lidocaine paracervical injection

Interventions

vaginal 2% Xylocaine

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

Intervention Type: DRUG

standard lidocaine paracervical block

1% lidocaine paracervical injection

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Planned Parenthood Mar Monte

San Jose, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27400015 (View on PubMed)

Other Identifiers

Vaginal Lidocaine

Identifier Type: -

Identifier Source: org_study_id