Paracervical Block for Pain Control in First Trimester Abortion

December 24, 2019 updated by: Oregon Health and Science University

An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion.

The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

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
    • Oregon
      • Portland, Oregon, United States, 97212
        • Planned Parenthood Columbia Willamette

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 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 18 years or older
  • Voluntarily requesting pregnancy termination
  • Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
  • Good general health
  • English or Spanish speaking
  • Be able and willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

  • Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions
  • Incomplete abortion
  • Required or requested narcotics or IV sedation (prior to randomization)
  • Patients who refuse Ibuprofen and paracervical blocks
  • Contraindications or allergies to lidocaine, ibuprofen or ativan
  • Significant physical or mental health condition
  • Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
  • Patients with known hepatic disease
  • Women, who in the opinion of the investigator are not suitable for the study protocol

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: No Paracervical Block for Pain Control
Subject will not receive a paracervical block during the procedure
Procedure: Sham Paracervical Block
In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.
ACTIVE_COMPARATOR: Paracervical Block for Pain Control
Subject will receive a paracervical block during the procedure.
Procedure: Paracervical Block
Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reported with cervical dilation
Time Frame: 1 Year
Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anticipated and reported pain at various time points
Time Frame: 1 Year

Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of anticipated pain) recorded prior to the procedure.

Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of positioning for procedure, speculum insertion, placement of the PCB, aspiration and 30 min postoperatively.
1 Year
Anxiety reported with the pain expected during the procedure and the procedure itself.
Time Frame: 1 Year
Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure.
1 Year
Satisfaction reported with pain control and overall procedure
Time Frame: 1 Year
Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure.
1 Year
Need for additional intraoperative and/or postoperative pain medication
Time Frame: 1 Year
Subjects may request additional pain medication once their procedure has begun or in recovery. The need for additional medication, and what medication was subsequently distributed, will be recorded.
1 Year

Collaborators and Investigators

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

Sponsor

Oregon Health and Science University

Collaborators

Planned Parenthood Federation of America

Investigators

  • Principal Investigator: Regina M Renner, MD, Oregon Health and Science University

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

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

April 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (ESTIMATE)

March 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHSU IRB 6071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 Sham Paracervical Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe