Pain Management, Cervical PreparationPhase 3NCT02852434
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
A Phase 3 study testing Lidocaine Gel (2%) and Lidocaine Paracervical Block (1%) in people with Pain Management, Cervical Preparation, run by Stanford University at 1 site in United States.
Trial summary
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Cervical Preparation
- What is being tested?
- Lidocaine Gel (2%) and Lidocaine Paracervical Block (1%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Apr 2017
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 and older
- Intrauterine pregnancy ≥16 weeks gestation
- English speaking competency
- Willing and able to sign consent forms
- Agree to comply with study procedures
Who cannot join
- Women less than 18 years of age
- IV conscious sedation
- Known allergy to study medication (lidocaine)
- Any women not meeting inclusion criteria above will be excluded from participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block.
- Conditions
- Pain Management, Cervical Preparation
- Being tested
- Lidocaine Gel (2%), Lidocaine Paracervical Block (1%)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Gel (2%)Drug
Lidocaine Paracervical Block (1%)Drug
| Study group | Role | What they receive |
|---|---|---|
| Self-administered Gel | Experimental | Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure Receives: Drug: Lidocaine Gel (2%) |
| Paracervical Block | Active comparator | Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement Receives: Drug: Lidocaine Paracervical Block (1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Measured: Intraoperative; Immediately (0-30 seconds) following cervical dilation
Secondary outcomes (4)
Anticipated Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Measured: Preoperative; 30 minutes prior to procedure
Baseline Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Measured: Immediately prior to procedure
Speculum Placement Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Measured: Intraoperative; Immediately following speculum placement
Overall Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Measured: Postoperative; Assessed once 10 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain Management, Cervical PreparationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852434
- Sponsor's protocol ID
- IRB-38200
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2016
- Last updated
- 7 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.
PubMed 30500336
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02852434
- Acronym / sponsor ID
- IRB-38200
- Conditions
- Pain Management, Cervical Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered Gel | Experimental | Drug: Lidocaine Gel (2%)Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure |
| Paracervical Block | Active comparator | Drug: Lidocaine Paracervical Block (1%)Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 and older
- Intrauterine pregnancy ≥16 weeks gestation
- English speaking competency
- Willing and able to sign consent forms
- Agree to comply with study procedures
Key exclusion criteria (4 listed)
- Women less than 18 years of age
- IV conscious sedation
- Known allergy to study medication (lidocaine)
- Any women not meeting inclusion criteria above will be excluded from participation
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 |
|---|---|---|
| Lidocaine Gel (2%) | Drug | Self-administered Gel |
| Lidocaine Paracervical Block (1%) | Drug | Paracervical Block |
Primary outcome
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
Time frame: Intraoperative; Immediately (0-30 seconds) following cervical dilation
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
4 secondary outcomes
Anticipated Pain Measured by Visual Analogue Scale
Time frame: Preoperative; 30 minutes prior to procedure
Baseline Pain Measured by Visual Analogue Scale
Time frame: Immediately prior to procedure
Speculum Placement Measured by Visual Analogue Scale
Time frame: Intraoperative; Immediately following speculum placement
Overall Pain Measured by Visual Analogue Scale
Time frame: Postoperative; Assessed once 10 minutes after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30500336Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.
- Individual participant dataSharing planned: No
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.
Principal Investigator, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Gel (2%) and Lidocaine Paracervical Block (1%) in people with Pain Management, Cervical Preparation, run by Stanford University at 1 site in United States.
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 5 inclusion and 4 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 Jun 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Apr 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 Perceived at the Time of Laminaria or Osmotic Dilator Insertion (time frame: Intraoperative; Immediately (0-30 seconds) following cervical dilation). 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 NCT02852434, which also lists 1 linked publication.
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 Jun 2019.