NCT02904915

Brief Summary

The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

September 8, 2016

Results QC Date

October 9, 2018

Last Update Submit

October 9, 2018

Conditions

AnalgesiaIUD Insertion

Outcome Measures

Primary Outcomes (3)

  • Pain Score as Assessed by a Visual Analogue Scale (VAS)

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

    baseline (about 30 seconds after insertion of the speculum)

  • Pain Score as Assessed by a Visual Analogue Scale

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

    about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)

  • Pain Score as Assessed by a Visual Analogue Scale

    The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

    about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)

Study Arms (2)

Paracervical block

ACTIVE COMPARATOR

Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Drug: LidocaineDevice: Intrauterine device (IUD)

No analgesia

ACTIVE COMPARATOR

IUD placement with no analgesia.

Other: No analgesiaDevice: Intrauterine device (IUD)

Interventions

LidocaineDRUG

Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Also known as: xylocaine, lignocaine
Paracervical block
No analgesiaOTHER

IUD placement without analgesia.

No analgesia
Intrauterine device (IUD)DEVICE

IUD placement with or without paracervical block with 1% lidocaine.

No analgesiaParacervical block

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

You may not qualify if:

  • Women with current pelvic inflammatory disease (PID)
  • Women who are not good candidates for an IUD
  • Patients who have a Lidocaine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

LidocaineIntrauterine Devices

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Limitations and Caveats

No Sham Block. Subjects had more variability in baseline pain scores (taken after speculum placement but prior to any procedure) than anticipated, and thus the study was underpowered.

Results Point of Contact

Title
Pamela D. Berens, MD
Organization
The University of Texas Health Science Center at Houston
Pamela.D.Berens@uth.tmc.edu
713-500-6471

Study Officials

  • Pamela D Berens, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 19, 2016

Study Start

January 12, 2017

Primary Completion

October 9, 2017

Study Completion

October 9, 2017

Last Updated

November 7, 2018

Results First Posted

November 7, 2018

Record last verified: 2018-10

Locations

US(1)