PainPhase 3NCT03508804
Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion
A Phase 3 study testing Lidocaine-Prilocaine Cream and 1% Lidocaine Paracervical Block in people with Pain, run by Stanford University at 1 site in United States.
Trial summary
The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall. 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
- What is being tested?
- Lidocaine-Prilocaine Cream and 1% Lidocaine Paracervical Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
- English or Spanish speaking;
- ability to give informed consent
Who cannot join
- pre-operative use of misoprostol;
- allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
- known uterine anomaly;
- prior cervical surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial
The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.
Read the detailed description
This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.
- Conditions
- Pain
- Being tested
- Lidocaine-Prilocaine Cream, Placebo Cream, 1% Lidocaine Paracervical Block
- Keywords
- surgical abortion, cervical anesthesia, pain control
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-Prilocaine CreamDrug
Also called EMLA
10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine
Placebo CreamDrug
10ml of vaginally self-administered placebo cream
1% Lidocaine Paracervical BlockDrug
Paracervical block of 10ml of 1% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-prilocaine cream | Experimental | 5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe Receives: Drug: Lidocaine-Prilocaine Cream; Drug: 1% Lidocaine Paracervical Block |
| Placebo cream (pain lucubrating gel) | Placebo comparator | 5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe Receives: Drug: Placebo Cream; Drug: 1% Lidocaine Paracervical Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
Measured: Intraoperative; Immediately following cervical dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508804
- Sponsor's protocol ID
- IRB-38207
- Status last verified
- May 2018
- First submitted
- 15 Jun 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03508804
- Acronym / sponsor ID
- IRB-38207
- Conditions
- Pain
- Keywords
- surgical abortion, cervical anesthesia, pain control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.
Detailed description
This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-prilocaine cream | Experimental | Drug: Lidocaine-Prilocaine Cream, Drug: 1% Lidocaine Paracervical Block5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe |
| Placebo cream (pain lucubrating gel) | Placebo comparator | Drug: Placebo Cream, Drug: 1% Lidocaine Paracervical Block5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;
- English or Spanish speaking;
- ability to give informed consent
Key exclusion criteria (4 listed)
- pre-operative use of misoprostol;
- allergy to study medications (lidocaine, prilocaine, versed, fentanyl);
- known uterine anomaly;
- prior cervical surgery
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-Prilocaine CreamAlso: EMLA10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine | Drug | Lidocaine-prilocaine cream |
| Placebo Cream10ml of vaginally self-administered placebo cream | Drug | Placebo cream (pain lucubrating gel) |
| 1% Lidocaine Paracervical BlockParacervical block of 10ml of 1% lidocaine | Drug | Lidocaine-prilocaine cream, Placebo cream (pain lucubrating gel) |
Primary outcome
Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation
Time frame: Intraoperative; Immediately following cervical dilation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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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.
Principal Investigator 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-Prilocaine Cream and 1% Lidocaine Paracervical Block in people with Pain, 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 3 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: withdrawn, as of the sponsor's last update on 16 May 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation (time frame: Intraoperative; Immediately following cervical dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2018.