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

Bridgeport Hospital

Status and phase: Completed; Phase 3

Conditions: Nonviable Pregnancy

Treatments: Drug: Lidocaine; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01708330

12-0039

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo gel

Placebo Comparator group

Description:

Placebo gel applied topically to the cervix

Treatment:

Drug: Placebo gel

Lidocaine gel

Experimental group

Description:

2% lidocaine gel applied topically to the cervix

Treatment:

Drug: Lidocaine