Pregnancy, UnwantedPhase 3SALSANCT02447029
Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
A Phase 3 study testing vaginal 2% Xylocaine and standard lidocaine paracervical block in people with Pregnancy, Unwanted, run by Stanford University at 1 site in United States.
Trial summary
Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no… 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
- Pregnancy, Unwanted
- What is being tested?
- vaginal 2% Xylocaine and standard lidocaine paracervical block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- 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 ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age
- Use of IV sedation for pain management
- English or Spanish speaking
- Ability to give informed consent
Who cannot join
- Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)
- Allergy to study medications: lidocaine, midazolam, fentanyl
- Known uterine anomaly
- Prior cervical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.
The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.
If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.
Read the detailed description
Abortion remains one of the most common surgical procedures in the world, regardless of region or development status [Guttmacher 2012]. In the United States, at least half of all women will experience an unintended pregnancy by age 45, and one third of all women will have had an abortion by this same age [Guttmacher 2014].
Despite universal efforts to increase the comfort of these procedures, pain remains a limiting factor in where and how abortion is performed. Recent estimates reveal that 70-97% of women experience pain during abortion [Renner 2010, Paul 2009, Belanger 1988]. Strategies to reduce all aspects of abortion related pain have the potential for significant public health impact, given the large number of women who seek these services. A survey of National Abortion Federation clinics found that to date, most providers (84%) employ the use of a lidocaine paracervical block for cervical anesthesia prior to abortion [O'Connell 2009], but traditionally without a waiting period between lidocaine administration and procedure initiation.
To the best of our knowledge, there are no published studies that 1) rigorously examine the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explore whether adequate pain relief is possible through self-administered, non-invasive means alone. The investigators propose to explore the effect of a locally applied lidocaine gel in place of the traditional paracervical block to decrease abortion related pain.
The objective of this study is to compare pain control at various time points during first trimester surgical abortion using a locally applied, patient-administered lidocaine gel as compared to traditional lidocaine paracervical block.
If a patient-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures, and perhaps replace paracervical injection altogether.
Hypothesis: Patients who receive lidocaine gel applied 30 minutes prior to first trimester surgical abortion will have pain control equivalent to that of a traditional paracervical block.
This is a non-inferiority, open-label, randomized controlled trial of women ages 18 and older undergoing first trimester surgical abortion at 50/7 to 116/7 weeks.
- Conditions
- Pregnancy, Unwanted
- Being tested
- vaginal 2% Xylocaine, standard lidocaine paracervical block
- Keywords
- abortion, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal 2% XylocaineDrug
patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block
standard lidocaine paracervical blockDrug
1% lidocaine paracervical injection
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Experimental | Drug: vaginal 2% Xylocaine Receives: Drug: vaginal 2% Xylocaine |
| standard lidocaine paracervical block | Other | standard lidocaine paracervical block Receives: Drug: standard lidocaine paracervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Measured: At time of cervical dilation, 30 minutes after lidocaine administration
Secondary outcomes (6)
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Measured: Pain level prior to procedure
Pain With Speculum Insertion as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Measured: Pain at time of speculum insertion
Pain With Tenaculum Placement as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Measured: Pain at time of tenaculum placement
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Measured: Pain prior to discharge home: 30-45 minutes after completion of procedure
Overall Satisfaction With Procedure as Measured by a Visual Analog Scale
This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.
Measured: 30-45 minutes after completion of procedure
Overall Complication Rate as Measured by a Count of Participants in Each Group
Measured: Rate of complications at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Pregnancy, UnwantedStudies 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447029
- Sponsor's protocol ID
- Vaginal Lidocaine
- Acronym
- SALSA
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2014
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Conti JA, Lerma K, Shaw KA, Blumenthal PD. Self-Administered Lidocaine Gel for Pain Control With First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):297-303. doi: 10.1097/AOG.0000000000001532.
PubMed 27400015
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02447029
- Acronym / sponsor ID
- SALSA / Vaginal Lidocaine
- Conditions
- Pregnancy, Unwanted
- Keywords
- abortion, pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.
The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.
If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.
Detailed description
Abortion remains one of the most common surgical procedures in the world, regardless of region or development status [Guttmacher 2012]. In the United States, at least half of all women will experience an unintended pregnancy by age 45, and one third of all women will have had an abortion by this same age [Guttmacher 2014].
Despite universal efforts to increase the comfort of these procedures, pain remains a limiting factor in where and how abortion is performed. Recent estimates reveal that 70-97% of women experience pain during abortion [Renner 2010, Paul 2009, Belanger 1988]. Strategies to reduce all aspects of abortion related pain have the potential for significant public health impact, given the large number of women who seek these services. A survey of National Abortion Federation clinics found that to date, most providers (84%) employ the use of a lidocaine paracervical block for cervical anesthesia prior to abortion [O'Connell 2009], but traditionally without a waiting period between lidocaine administration and procedure initiation.
To the best of our knowledge, there are no published studies that 1) rigorously examine the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explore whether adequate pain relief is possible through self-administered, non-invasive means alone. The investigators propose to explore the effect of a locally applied lidocaine gel in place of the traditional paracervical block to decrease abortion related pain.
The objective of this study is to compare pain control at various time points during first trimester surgical abortion using a locally applied, patient-administered lidocaine gel as compared to traditional lidocaine paracervical block.
If a patient-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures, and perhaps replace paracervical injection altogether.
Hypothesis: Patients who receive lidocaine gel applied 30 minutes prior to first trimester surgical abortion will have pain control equivalent to that of a traditional paracervical block.
This is a non-inferiority, open-label, randomized controlled trial of women ages 18 and older undergoing first trimester surgical abortion at 50/7 to 116/7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Experimental | Drug: vaginal 2% XylocaineDrug: vaginal 2% Xylocaine |
| standard lidocaine paracervical block | Other | Drug: standard lidocaine paracervical blockstandard lidocaine paracervical block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age
- Use of IV sedation for pain management
- English or Spanish speaking
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)
- Allergy to study medications: lidocaine, midazolam, 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 |
|---|---|---|
| vaginal 2% Xylocainepatient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block | Drug | Active Comparator |
| standard lidocaine paracervical block1% lidocaine paracervical injection | Drug | standard lidocaine paracervical block |
Primary outcome
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale
Time frame: At time of cervical dilation, 30 minutes after lidocaine administration
This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
6 secondary outcomes
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale
Time frame: Pain level prior to procedure
Pain With Speculum Insertion as Measured by a Visual Analog Scale
Time frame: Pain at time of speculum insertion
Pain With Tenaculum Placement as Measured by a Visual Analog Scale
Time frame: Pain at time of tenaculum placement
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale
Time frame: Pain prior to discharge home: 30-45 minutes after completion of procedure
Overall Satisfaction With Procedure as Measured by a Visual Analog Scale
Time frame: 30-45 minutes after completion of procedure
Overall Complication Rate as Measured by a Count of Participants in Each Group
Time frame: Rate of complications at the end of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27400015Conti JA, Lerma K, Shaw KA, Blumenthal PD. Self-Administered Lidocaine Gel for Pain Control With First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):297-303. doi: 10.1097/AOG.0000000000001532.
Related trials for Pregnancy, Unwanted
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys
Pregnancy (Unwanted), Sexually Transmitted Disease (STD)
Active, not recruitingObservational study
Consequences of Unwanted Pregnancy in Nepal
Unwanted Pregnancy
Not yet recruiting
The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies
Mindfulness Compassionate Living Training
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.
The record lists no contact. Use the official record to reach the sponsor.
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 vaginal 2% Xylocaine and standard lidocaine paracervical block in people with Pregnancy, Unwanted, 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 4 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 14 Feb 2024. 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 24 Jul 2017). 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?
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (time frame: At time of cervical dilation, 30 minutes after lidocaine administration). 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 NCT02447029, 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 14 Feb 2024.