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

Phase 3

Withdrawn

• Conditions: Pain
• Interventions: Drug: Lidocaine-Prilocaine Cream; Drug: Placebo Cream; Drug: 1% Lidocaine Paracervical Block

• Registration Number: NCT03508804
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16
• Study Start: 2020-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• pre-operative use of misoprostol;
• allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
• known uterine anomaly;
• prior cervical surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo cream (pain lucubrating gel)	1% Lidocaine Paracervical Block	5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe
Lidocaine-prilocaine cream	Lidocaine-Prilocaine Cream	5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe
Lidocaine-prilocaine cream	1% Lidocaine Paracervical Block	5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe
Placebo cream (pain lucubrating gel)	Placebo Cream	5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe

Primary Outcome Measures

Name	Time	Method
Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation	Intraoperative; Immediately following cervical dilation

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Stanford, California, United States