Paracervical Block for Pain Associated With Laminaria Insertion

University of Hawaii

Status: Completed

Conditions: Pain

Treatments: Drug: Sham paracervical block; Drug: Paracervical Block with lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02454296

22702

Details and patient eligibility

About

To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Full description

Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women between the ages of 18-49 years
• Desiring surgical termination of pregnancy or surgical management of a fetal demise
• Treatment plan involves cervical preparation with laminaria
• Participant able to provide informed consent in English and willing to participate in the study

Exclusion criteria

• Unable to read/speak/understand English
• Contraindications to receiving lidocaine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Paracervical Block with lidocaine

Active Comparator group

Description:

A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.

Treatment:

Drug: Paracervical Block with lidocaine

Sham paracervical block

Sham Comparator group

Description:

A sham block will be done prior to the placement of laminaria using a capped needle

Treatment:

Drug: Sham paracervical block