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

Stanford University

Status and phase: Withdrawn; Phase 3

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03508804

IRB-38207

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Lidocaine-prilocaine cream

Experimental group

Description:

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

Treatment:

Drug: Lidocaine-Prilocaine Cream

Drug: 1% Lidocaine Paracervical Block

Placebo cream (pain lucubrating gel)

Placebo Comparator group

Description:

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

Treatment:

Drug: 1% Lidocaine Paracervical Block

Drug: Placebo Cream