Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion

Pain Clinical Trial

Official title:

Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03508804
• Other study ID #: IRB-38207
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.

Description:

This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;

• English or Spanish speaking;

• ability to give informed consent

Exclusion Criteria:

• pre-operative use of misoprostol;

• allergy to study medications (lidocaine, prilocaine, versed, fentanyl);

• known uterine anomaly;

• prior cervical surgery

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine-Prilocaine Cream
10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine
• Placebo Cream
10ml of vaginally self-administered placebo cream
• 1% Lidocaine Paracervical Block
Paracervical block of 10ml of 1% lidocaine

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation		Intraoperative; Immediately following cervical dilation