Pain
Conditions
Keywords
Intrauterine Device, Pain, Lidocaine
Brief summary
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.
Detailed description
Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion. This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion. If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.
Interventions
DRUGLidocaine
Intravaginal insertion of 4mL 2% lidocaine gel
DRUGPlacebo
KY Jelly
Sponsors
Society of Family Planning
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age * Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) * No history of pregnancy in the last 6 weeks * Able to provide written informed consent in English and comply with all study procedures
Exclusion criteria
* Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics * Prior failed IUD insertion * Prior IUD use * Use of narcotic or benzodiazepine medication within the last 24 hours * U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD * Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain From Baseline to IUD Insertion | change in pain score from baseline (before IUD insertion) to time of IUD insertion | To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | After inserting the gel but prior to IUD insertion | Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale |
| Percentage of IUDs Considered by Physicians Easy to Insert | Directly after IUD insertion | The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group. |
| Need for Pain Medication up to 7 Days | 7 days post-insertion | Number of women taking pain medication for at least one day following IUD insertion |
Countries
United States
Participant flow
Recruitment details
In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.
Pre-assignment details
* 2 patients were removed from the study. Patients were considered screen failures before randomization to an arm. * 18 declined participation; 10 (56%) reported time concerns as their primary reason for declining.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Intravaginal 2% Lidocaine Gel 4mL of 2% lidocaine gel for vaginal self-administration
) | 30 |
| Group 2: Intravaginal Placebo Gel 4mL placebo gel (K-Y Jelly) for vaginal self-administration | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1: Intravaginal 2% Lidocaine Gel | Group 2: Intravaginal Placebo Gel | Total |
|---|---|---|---|
| Age, Customized Between 14-50 | 30 participants | 29 participants | 59 participants |
| Gender Female | 30 Participants | 29 Participants | 59 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Change in Pain From Baseline to IUD Insertion
To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).
Time frame: change in pain score from baseline (before IUD insertion) to time of IUD insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Intravaginal 2% Lidocaine Gel | Change in Pain From Baseline to IUD Insertion | 61 change in visual analog scale score |
| Group 2: Intravaginal Placebo Gel | Change in Pain From Baseline to IUD Insertion | 68 change in visual analog scale score |
Secondary
Need for Pain Medication up to 7 Days
Number of women taking pain medication for at least one day following IUD insertion
Time frame: 7 days post-insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Intravaginal 2% Lidocaine Gel | Need for Pain Medication up to 7 Days | 24 participants |
| Group 2: Intravaginal Placebo Gel | Need for Pain Medication up to 7 Days | 27 participants |
Secondary
Percentage of IUDs Considered by Physicians Easy to Insert
The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group.
Time frame: Directly after IUD insertion
Population: Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Intravaginal 2% Lidocaine Gel | Percentage of IUDs Considered by Physicians Easy to Insert | 87 percentage of insertions declared easy |
| Group 2: Intravaginal Placebo Gel | Percentage of IUDs Considered by Physicians Easy to Insert | 64 percentage of insertions declared easy |
Secondary
To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD
Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale
Time frame: After inserting the gel but prior to IUD insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Intravaginal 2% Lidocaine Gel | To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | 29 participants who found gel easy to use |
| Group 2: Intravaginal Placebo Gel | To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | 29 participants who found gel easy to use |