Paracervical Block for Pain Associated With Laminaria Insertion
Overview
- Phase
- Not Applicable
- Intervention
- Paracervical Block with lidocaine
- Conditions
- Pain
- Sponsor
- University of Hawaii
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Pain After Placement of Laminaria (100 mm Visual Analog Scale)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
Detailed 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.
Investigators
Reni Soon
Assistant Professor
University of Hawaii
Eligibility Criteria
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
Arms & Interventions
Paracervical Block with lidocaine
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Intervention: Paracervical Block with lidocaine
Sham paracervical block
A sham block will be done prior to the placement of laminaria using a capped needle
Intervention: Sham paracervical block
Outcomes
Primary Outcomes
Pain After Placement of Laminaria (100 mm Visual Analog Scale)
Time Frame: Measured within 10 seconds after placement of laminaria
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.
Secondary Outcomes
- Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)(15 minutes post-operatively)
- Paracervical or Sham Block Pain(Within 10 seconds after receiving paracervical or sham block)