Paracervical Block for Pain Associated With Laminaria Insertion

University of Hawaii41 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

Paracervical Block with lidocaineDRUG

Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion

Sham paracervical blockDRUG

A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Women's Health Specialists

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

Pain After Placement of Laminaria (100 mm Visual Analog Scale)

We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.

Time frame: Measured within 10 seconds after placement of laminaria

Secondary Outcomes

Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)

Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied

Time frame: 15 minutes post-operatively

Paracervical or Sham Block Pain

Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.

Time frame: Within 10 seconds after receiving paracervical or sham block

Data from ClinicalTrials.gov

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