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

NCT03508804 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: IRB-38207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

surgical abortion; cervical anesthesia; pain control

Outcome Measures

Primary Outcomes (1)

• Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation

  Intraoperative; Immediately following cervical dilation

Study Arms (2)

Lidocaine-prilocaine cream

EXPERIMENTAL

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

Drug: Lidocaine-Prilocaine Cream; Drug: 1% Lidocaine Paracervical Block

Placebo cream (pain lucubrating gel)

PLACEBO COMPARATOR

5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe

Drug: Placebo Cream; Drug: 1% Lidocaine Paracervical Block

Interventions

Lidocaine-Prilocaine Cream DRUG

10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine

Also known as: EMLA

Lidocaine-prilocaine cream

Placebo Cream DRUG

10ml of vaginally self-administered placebo cream

Placebo cream (pain lucubrating gel)

1% Lidocaine Paracervical Block DRUG

Paracervical block of 10ml of 1% lidocaine

Lidocaine-prilocaine cream; Placebo cream (pain lucubrating gel)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
• English or Spanish speaking;
• ability to give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Principal Investigator

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: April 26, 2018
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)