Pain
Conditions
Keywords
Pain measurement, Intrauterine devices, Lidocaine
Brief summary
The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.
Interventions
DRUG2% lidocaine gel
120mg lidocaine x 1
DRUGPlacebo gel
Inert gel x 1
Sponsors
Society of Family Planning
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. plans for IUD insertion for contraception or abnormal uterine bleeding; 2. 18 to 49 years of age; 3. reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant; 4. no prior IUD use; 5. not taken analgesics or anxiolytics in the previous 24 hours; 6. not taken misoprostol prior to IUD insertion; 7. the ability and are willing to give informed consent; 8. speaks English or Spanish.
Exclusion criteria
1. any contraindication to IUD placement; 2. allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel; 3. chronic narcotic/benzodiazepine/barbiturate use within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score During IUD Insertion | Day 1 | 0 to 100 mm visual analog scale, higher values represent more pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Placebo gel: Inert gel x 1 | 73 |
| Study Group Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
2% lidocaine gel: 120mg lidocaine x 1 | 72 |
| Total | 145 |
Baseline characteristics
| Characteristic | Control Group | Study Group | Total |
|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 5 | 26.2 years STANDARD_DEVIATION 5.3 | 25.7 years STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 73 Participants | 72 Participants | 145 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 | 1 / 73 | 1 / 72 |
| serious Total, serious adverse events | 0 / 73 | 0 / 72 |
Outcome results
Primary
Mean Pain Score During IUD Insertion
0 to 100 mm visual analog scale, higher values represent more pain.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Mean Pain Score During IUD Insertion | 36.7 score on a scale | Standard Deviation 30 |
| Study Group | Mean Pain Score During IUD Insertion | 35.2 score on a scale | Standard Deviation 27.7 |