Pain
Conditions
Keywords
IUD, Lidocaine gel
Brief 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. 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.
Interventions
DRUG2% lidocaine gel
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.
OTHERplacebo
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.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Lidocaine allergy * First trimester abortion or miscarriage in the previous six weeks * Second trimester abortion or miscarriage in the previous 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain During IUD Insertion at Various Time Points (See Description for Time Points) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | During IUD insertion | — |
| Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale | during IUD insertion | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Gel This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: 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. | 100 |
| Placebo Gel (Surgilube) This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: 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. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Placebo Gel (Surgilube) | Total | Lidocaine Gel |
|---|---|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 6 | 27.4 years STANDARD_DEVIATION 6 | 27.1 years STANDARD_DEVIATION 6 |
| Anticipated pain | 57.2 units on a 100 mm visual analogue scale STANDARD_DEVIATION 28 | 56.6 units on a 100 mm visual analogue scale STANDARD_DEVIATION 27 | 56.0 units on a 100 mm visual analogue scale STANDARD_DEVIATION 26 |
| Dysmenorrhea | 32.3 units on a 100mm Visual Analogue Scale STANDARD_DEVIATION 28 | 34.6 units on a 100mm Visual Analogue Scale STANDARD_DEVIATION 28 | 36.8 units on a 100mm Visual Analogue Scale STANDARD_DEVIATION 29 |
| IUD type Copper IUD | 68 participants | 138 participants | 70 participants |
| IUD type Levonogestrel IUD | 32 participants | 62 participants | 30 participants |
| Parity Nulliparous | 21 participants | 60 participants | 39 participants |
| Parity Parous | 79 participants | 140 participants | 61 participants |
| Race/Ethnicity, Customized Caucasian | 12 participants | 27 participants | 15 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 81 participants | 153 participants | 72 participants |
| Race/Ethnicity, Customized Other | 7 participants | 20 participants | 13 participants |
| Sex: Female, Male Female | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male 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 | 17 / 100 | 16 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
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.
Time frame: During IUD insertion (see above description for which time points)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine Gel | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Tenaculum placement | 35.4 units on a 100 mm visual analogue scale | Standard Deviation 26 |
| Lidocaine Gel | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Uterine sounding | 55.5 units on a 100 mm visual analogue scale | Standard Deviation 30 |
| Lidocaine Gel | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | IUD insertion | 51.0 units on a 100 mm visual analogue scale | Standard Deviation 31 |
| Lidocaine Gel | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Speculum removal | 20 units on a 100 mm visual analogue scale | Standard Deviation 43 |
| Placebo Gel (Surgilube) | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Speculum removal | 20 units on a 100 mm visual analogue scale | Standard Deviation 45 |
| Placebo Gel (Surgilube) | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Tenaculum placement | 34.3 units on a 100 mm visual analogue scale | Standard Deviation 25 |
| Placebo Gel (Surgilube) | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | IUD insertion | 50.9 units on a 100 mm visual analogue scale | Standard Deviation 32 |
| Placebo Gel (Surgilube) | Pain During IUD Insertion at Various Time Points (See Description for Time Points) | Uterine sounding | 51.6 units on a 100 mm visual analogue scale | Standard Deviation 25 |
Secondary
Adverse Events
Time frame: During IUD insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lidocaine Gel | Adverse Events | Nausea | 8 participants |
| Lidocaine Gel | Adverse Events | Vomiting | 0 participants |
| Lidocaine Gel | Adverse Events | Dizziness | 9 participants |
| Placebo Gel (Surgilube) | Adverse Events | Nausea | 4 participants |
| Placebo Gel (Surgilube) | Adverse Events | Vomiting | 0 participants |
| Placebo Gel (Surgilube) | Adverse Events | Dizziness | 12 participants |
Secondary
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.
Time frame: during IUD insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Gel | Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale | 63.8 units on a 100 mm visual analogue scale | Standard Deviation 27 |
| Placebo Gel (Surgilube) | Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale | 35.3 units on a 100 mm visual analogue scale | Standard Deviation 26 |