Study of Pain Control With Hormonal IUS Insertion

NCT02352714 | Completed Phase 4

• 1 other identifier: 14-011286
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

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).

Conditions

Pain

Keywords

Adolescents; Women's Health; Contraception; Reproduction; Comparative Effectiveness Research; Pregnancy Prevention; Intrauterine Device

Outcome Measures

Primary Outcomes (1)

• Self-reported pain

  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)

Study Arms (2)

Paracervical Nerve Block

ACTIVE COMPARATOR

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

Sham Paracervical Block

SHAM COMPARATOR

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

Interventions

Paracervical Nerve Block DRUG

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block

Also known as: 1 % Lidocaine

Paracervical Nerve Block

Sham Paracervical Block DRUG

Block randomization to receive lidocaine paracervical nerve block vs sham cervical block

Also known as: Blunt End of a Q-Tip

Sham Paracervical Block

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Bayer: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (23)

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• Akers AY, Harding J, Perriera LK, Schreiber C, Garcia-Espana JF, Sonalkar S. Satisfaction With the Intrauterine Device Insertion Procedure Among Adolescent and Young Adult Women. Obstet Gynecol. 2018 Jun;131(6):1130-1136. doi: 10.1097/AOG.0000000000002596.

  PMID: 29742656 DERIVED

• Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.

  PMID: 28885425 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Obstetrical; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Aletha Y Akers, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)