SOPHI: Study of Pain Control With Hormonal IUS Insertion

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT02352714

Collaborator

Bayer (Industry), University of Pennsylvania (Other)

Enrollment

Locations

Arms

Duration (Months)

32.7

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Paracervical Nerve Block Drug: Sham Paracervical Block	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Self-reported pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 22 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
2	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
3	Thomas Jefferson University Hospitals	Philadelphia	Pennsylvania	United States	19107