AnalgesiaPhase 4NCT02904915

Paracervical Block Versus No Paracervical Block During IUD Insertion

A Phase 4 study testing Lidocaine, No analgesia and Intrauterine device (IUD) in people with Analgesia and IUD Insertion, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 52 years, women only
Conditions the study is for: Analgesia, IUD Insertion
What is being tested?: Lidocaine, No analgesia and Intrauterine device (IUD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 12 Jan 2017to 9 Oct 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 52 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Analgesia, IUD Insertion
Being tested: Lidocaine, No analgesia, Intrauterine device (IUD)
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LidocaineDrug
Also called xylocaine, lignocaine
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
No analgesiaOther
IUD placement without analgesia.
Intrauterine device (IUD)Device
IUD placement with or without paracervical block with 1% lidocaine.

Study groups in NCT02904915
Study group	Role	What they receive
Paracervical block	Active comparator	Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Receives: Drug: Lidocaine; Device: Intrauterine device (IUD)
No analgesia	Active comparator	IUD placement with no analgesia. Receives: Other: No analgesia; Device: Intrauterine device (IUD)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 20179 Oct 2017

First posted19 Sep 2016 (estimated)
Study start12 Jan 2017
Primary completion9 Oct 2017
Study completion9 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnalgesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02904915
Sponsor's protocol ID: HSC-MS-16-0664
Status last verified: Oct 2018
First submitted: 8 Sep 2016
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paracervical Block Versus No Paracervical Block During IUD Insertion
ClinicalTrials.gov ID: NCT02904915
Acronym / sponsor ID: HSC-MS-16-0664
Conditions: Analgesia, IUD Insertion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 12 Jan 2017 (actual)
Primary completion: 9 Oct 2017 (actual)
Study completion: 9 Oct 2017 (actual)
First posted: 19 Sep 2016 (estimated)
Results: Posted 7 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paracervical block	Active comparator	Drug: Lidocaine, Device: Intrauterine device (IUD)Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
No analgesia	Active comparator	Other: No analgesia, Device: Intrauterine device (IUD)IUD placement with no analgesia.

Who may qualify

Ages: 18 to 52 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LidocaineAlso: xylocaine, lignocaineIntrauterine device (IUD) placement with paracervical block with 1% lidocaine.	Drug	Paracervical block
No analgesiaIUD placement without analgesia.	Other	No analgesia
Intrauterine device (IUD)IUD placement with or without paracervical block with 1% lidocaine.	Device	No analgesia, Paracervical block

Primary outcome

Pain Score as Assessed by a Visual Analogue Scale (VAS)
Time frame: baseline (about 30 seconds after insertion of the speculum)
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).
Pain Score as Assessed by a Visual Analogue Scale
Time frame: about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)
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).
Pain Score as Assessed by a Visual Analogue Scale
Time frame: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)
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).

Results and safety

Results posted to the registry on 7 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracervical Block	25	25
No Analgesia	25	25

Primary outcome: Pain Score as Assessed by a Visual Analogue Scale (VAS)

Time frame: baseline (about 30 seconds after insertion of the speculum). Mean (Standard Deviation). Unit: units on a scale

Measure	Paracervical Block n = 25	No Analgesia n = 25
Value	2.4 (2.3)	2.1 (2.4)

Paracervical Block vs No Analgesia: p = 0.59, Fisher Exact

Primary outcome: Pain Score as Assessed by a Visual Analogue Scale

Time frame: about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum). Mean (Standard Deviation). Unit: units on a scale

Measure	Paracervical Block n = 25	No Analgesia n = 25
Value	2.1 (2.5)	2.7 (2.4)

Paracervical Block vs No Analgesia: p = 0.39, Fisher Exact

Primary outcome: Pain Score as Assessed by a Visual Analogue Scale

Time frame: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum). Mean (Standard Deviation). Unit: units on a scale

Measure	Paracervical Block n = 25	No Analgesia n = 25
Value	2.6 (2.7)	3.6 (2.9)

Paracervical Block vs No Analgesia: p = 0.23, Fisher Exact

Adverse events

Time frame: From time of speculum placement until the patient left the office (patient leaves office about 3-5 minutes after the procedure, for a total of about 15 minutes from speculum placement to leaving the office).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paracervical Block	0 of 25 (0%)	0 of 25 (0%)	0 of 25
No Analgesia	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela D Berens, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score as Assessed by a Visual Analogue Scale (VAS) (time frame: baseline (about 30 seconds after insertion of the speculum)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02904915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.