Study of Pain Control With Hormonal IUS Insertion (SOPHI)

September 12, 2018 updated by: Children's Hospital of Philadelphia

Study of Pain Control With Hormonal IUS Insertion (SOPHI Study)

This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a paracervical (n=46) block versus a sham paracervical block (n=46).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrauterine systems (IUS) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy. Despite this, uptake of IUSs among U.S. young women aged 14 to 22 years has been low. Increasing the use of this effective, long acting contraception among young women is an important public health goal, as it could help to reduce the high rates of unintended pregnancies in this population.

A major barrier to young women's utilization of IUSs is fear of pain during insertion. Unfortunately, studies evaluating methods of pain control during IUS insertion have focused on adult women, leaving the question unanswered as to the best pain management method for young women. Compared to adult women, young women have less experience with pelvic exams and may therefore derive greater benefit from pain control measures during gynecologic procedures, such as IUS insertions. Young women and their providers are seeking effective pain control options; yet, there is a lack of high quality, comparative effectiveness research to guide decision making. This proposal seeks to fill this important gap.

With the introduction of the Skyla IUS (Bayer Healthcare Pharmaceuticals, Inc.) to the U.S. market in January 2013, a new approach to pain management became possible. Skyla is smaller than existing IUSs and may therefore cause less pain during insertion. The pain response triggered during Skyla insertion may be better controlled by existing pain control options. This is the underlying premise of this study.

In addition to the size of an IUS, theoretical and empirical data suggest that paracervical blocks have the greatest promise for pain control during IUS insertion compared to other pain control options. Paracervical infiltration of a local anesthetic into the cervix interrupts the visceral sensory fibers of the lower uterus, cervix, and upper vagina. Data from several clinical trials indicate that paracervical blocks provide clinically significant control of pain during multiple types of gynecologic procedures. One recently published study evaluated the effectiveness of paracervical blocks during IUS insertion and found a marginally significant reduction in pain, but the study was underpowered and focused on adult women. The value of a paracervical block in young women receiving an IUS remains unclear.

The investigator propose to conduct a randomized, controlled single-blind trial comparing pain with Skyla IUS insertion among young women aged 14 to 22 years randomized to receive a paracervical block versus a sham cervical block. This study will provide important information for counseling young women about pain management during IUS insertion.

Study Type

Interventional

Enrollment (Actual)

98

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospitals

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

14 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous (i.e., no pregnancy > 24 weeks)
  • Not currently pregnant
  • Not pregnant in the past 6 weeks
  • Willing to be randomized to a paracervical nerve block or sham paracervical block group
  • Interested in using an intrauterine system (IUS)
  • Able to read and provide written informed consent in English

Exclusion Criteria:

  • An allergy, hypersensitivity, or absolute medical contra-indication to using lidocaine, other amino-amide local anesthetics, or to non-steroidal anti-inflammatory agents, such as ibuprofen
  • A history of epilepsy or peptic ulcer disease
  • Moderate to severe asthma that precludes non-steroidal anti-inflammatory drug (NSAID) use
  • Hepatic or renal failure
  • Moderate to severe cardiac disease
  • Previous use of an IUS or a history of a prior failed IUS insertion
  • Use of a narcotic or benzodiazepine in the past 24 hours
  • Positive pregnancy test or reasonable risk of pregnancy
  • Current cervicitis
  • Intrauterine infection in the past 90 days
  • Meet Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for IUS use
  • Currently breastfeeding

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Paracervical Nerve Block
Ten milliliters of 1% lidocaine paracervical anesthetic will be injected at three cervical locations: 1 mL at the tenaculum site (12 o'clock on a clock face) and 4.5 mL each at the 4 o'clock and 8 o'clock positions. A 3 minute waiting period will be used between the administration of the paracervical nerve block and the insertion of IUS to allow the paracervical block to take effect.
Drug: Paracervical Nerve Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Other Names:
  • 1 % Lidocaine
SHAM_COMPARATOR: Sham Paracervical Block
To perform the sham cervical block, the cervix will be touched with the blunt end of a Q-tip at the three locations described above for the paracervical block. The cervical mucosa will not be broken during the sham block. A 3 minute waiting period will again occur between administration of the sham block and IUS insertion to be consistent with the procedure used for the nerve block.
Drug: Sham Paracervical Block
Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Other Names:
  • Blunt End of a Q-Tip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported pain
Time Frame: Intraoperative (At the time of insertion of the IUS)
The primary outcome will be assessed using a visual analogue scale (VAS). Assessment will occur at the time of the insertion of the IUS device. The IUS will be placed according to manufacturer's recommendation.
Intraoperative (At the time of insertion of the IUS)

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania
Bayer

Investigators

  • Principal Investigator: Aletha Y Akers, MD, MPH, Children's Hospital of Philadelphia

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

January 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-011286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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