Paracervical Block for Pain Associated With Laminaria Insertion

March 2, 2017 updated by: Reni Soon, University of Hawaii
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • University Women's Health Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paracervical Block with lidocaine
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Drug: Paracervical Block with lidocaine
Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
Other Names:
  • Paracervical block
Sham Comparator: Sham paracervical block
A sham block will be done prior to the placement of laminaria using a capped needle
Drug: Sham paracervical block
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
Other Names:
  • Sham block; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured within 10 seconds after placement of laminaria

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
Time Frame: 15 minutes post-operatively
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
15 minutes post-operatively
Paracervical or Sham Block Pain
Time Frame: Within 10 seconds after receiving paracervical or sham block
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.
Within 10 seconds after receiving paracervical or sham block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Paracervical Block with lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe