PainNCT01214161
Intracervical Lidocaine Gel for IUD Insertional Pain
A study testing 2% lidocaine gel in people with Pain, run by Columbia University at 1 site in United States.
Trial summary
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 2% lidocaine gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2013
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
- Age 18-45
- Speak English or Spanish
Who cannot join
- Lidocaine allergy
- First trimester abortion or miscarriage in the previous six weeks
- Second trimester abortion or miscarriage in the previous 12 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Planning Clinic / Columbia University Family Planning Practice
New York, New York, 10032
About this study
Official title: Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.
This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain
Read the detailed description
The intrauterine device (IUD) is a highly effective, long-acting, reversible method of contraception used by approximately 8% of women in the developed world. In the United States, historically candidates for IUDs were monogamous, parous women. Recent research has shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous women. Nulliparous and parous women can experience significant amounts of pain during IUD insertion. Concerns about insertional pain could be a barrier to IUD initiation women and their healthcare providers.
This study will recruit women at either the Family Planning Clinic or the offices of Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for birth control. Women who consent to participating in the study will be randomized to two groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement and the other group will receive a placebo inert gel. The primary objective of this study is to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring of the uterus) and at speculum removal; these are standard procedures during IUD insertion. Secondary outcomes include provider assessment of the patient's pain, patient's level of satisfaction with the insertion, and whether any adverse events such as nausea/vomiting, fainting, or IUD insertion failure occurred.
- Conditions
- Pain
- Being tested
- 2% lidocaine gel, placebo
- Keywords
- IUD, Lidocaine gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaine gelDrug
Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
placeboOther
Also called surgilube
Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control/placebo group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine gel | Experimental | This group will be those randomized to receiving the intervention with 2% lidocaine gel. Receives: Drug: 2% lidocaine gel |
| placebo gel (surgilube) | Placebo comparator | This group will be randomized to having the intervention with the placebo surgilube gel. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
Measured: During IUD insertion (see above description for which time points)
Secondary outcomes (2)
Adverse Events
Measured: During IUD insertion
Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale
This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.
Measured: during IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionJun 2013
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 PainStudies of the same condition, open and under way.
- More trials run by Columbia 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Davis, Columbia University
- Investigators
- Anne Davis, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214161
- Sponsor's protocol ID
- AAAE9330
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2010
- Last updated
- 7 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.
PubMed 22325115
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01214161
- Acronym / sponsor ID
- AAAE9330
- Conditions
- Pain
- Keywords
- IUD, Lidocaine gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 7 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.
This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain
Detailed description
The intrauterine device (IUD) is a highly effective, long-acting, reversible method of contraception used by approximately 8% of women in the developed world. In the United States, historically candidates for IUDs were monogamous, parous women. Recent research has shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous women. Nulliparous and parous women can experience significant amounts of pain during IUD insertion. Concerns about insertional pain could be a barrier to IUD initiation women and their healthcare providers.
This study will recruit women at either the Family Planning Clinic or the offices of Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for birth control. Women who consent to participating in the study will be randomized to two groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement and the other group will receive a placebo inert gel. The primary objective of this study is to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring of the uterus) and at speculum removal; these are standard procedures during IUD insertion. Secondary outcomes include provider assessment of the patient's pain, patient's level of satisfaction with the insertion, and whether any adverse events such as nausea/vomiting, fainting, or IUD insertion failure occurred.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine gel | Experimental | Drug: 2% lidocaine gelThis group will be those randomized to receiving the intervention with 2% lidocaine gel. |
| placebo gel (surgilube) | Placebo comparator | Other: placeboThis group will be randomized to having the intervention with the placebo surgilube gel. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
- Age 18-45
- Speak English or Spanish
Key exclusion criteria (3 listed)
- Lidocaine allergy
- First trimester abortion or miscarriage in the previous six weeks
- Second trimester abortion or miscarriage in the previous 12 weeks
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 |
|---|---|---|
| 2% lidocaine gelParticipants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel. Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room. | Drug | lidocaine gel |
| placeboAlso: surgilubeParticipants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control/placebo group with an inert gel similar in appearance, color and consistency to the lidocaine gel. Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room. | Other | placebo gel (surgilube) |
Primary outcome
Pain During IUD Insertion at Various Time Points (See Description for Time Points)
Time frame: During IUD insertion (see above description for which time points)
Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.
2 secondary outcomes
Adverse Events
Time frame: During IUD insertion
Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale
Time frame: during IUD insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22325115Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.
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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.
Anne Davis, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% lidocaine gel in people with Pain, run by Columbia 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 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 Apr 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2016). 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 During IUD Insertion at Various Time Points (See Description for Time Points) (time frame: During IUD insertion (see above description for which time points)). 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 NCT01214161, 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 Apr 2016.