The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

Phase 3

Completed

• Conditions: Nonviable Pregnancy
• Interventions: Drug: Placebo gel; Drug: Lidocaine

• Registration Number: NCT01708330
• Lead Sponsor: Bridgeport Hospital

Brief Summary

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women \& Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2015-07
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Patient at the Women and Infants Triage/Women's Emergency Department
• Vital signs are stable
• Ages 18 and older
• Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
• Estimated gestational age up to 10 weeks
• Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
• Able to read English or Spanish
• Able to give informed consent for involvement in the study

Exclusion Criteria

• Allergic to lidocaine, iodine or betadine
• Known sensitivity to any component of the lidocaine or placebo gel.
• In acute distress
• Unable to give informed consent
• Unable to read English or Spanish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo gel	Placebo gel	Placebo gel applied topically to the cervix
Lidocaine gel	Lidocaine	2% lidocaine gel applied topically to the cervix

Primary Outcome Measures

Name	Time	Method
Pain during intracervical block	immediate	Pain on visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Pain during tenaculum placement	immediate	Pain on visual analogue scale
Pain during cervical dilation	immediate	Pain on visual analogue scale
Pain during uterine aspiration	immediate	Pain on visual analogue scale

Trial Locations

Locations (1)

Women and Infants Hospital Triage; 🇺🇸 Providence, Rhode Island, United States