Analgesia, IUD Insertion
Conditions
Brief summary
The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
Interventions
DRUGLidocaine
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
OTHERNo analgesia
IUD placement without analgesia.
IUD placement with or without paracervical block with 1% lidocaine.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No
Inclusion criteria
* Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
Exclusion criteria
* Women with current pelvic inflammatory disease (PID) * Women who are not good candidates for an IUD * Patients who have a Lidocaine allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score as Assessed by a Visual Analogue Scale (VAS) | baseline (about 30 seconds after insertion of the speculum) | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). |
| Pain Score as Assessed by a Visual Analogue Scale | about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum) | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracervical Block Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. | 25 |
| No Analgesia IUD placement with no analgesia.
No analgesia: IUD placement without analgesia.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Age, Continuous | 24.6 years STANDARD_DEVIATION 4.6 | 26.6 years STANDARD_DEVIATION 5.9 | 25.6 years STANDARD_DEVIATION 5.4 |
| Contraception History Condoms (female and male) | 3 Participants | 2 Participants | 5 Participants |
| Contraception History Depo Provera/injections | 7 Participants | 3 Participants | 10 Participants |
| Contraception History Intrauterine device (IUD) | 1 Participants | 5 Participants | 6 Participants |
| Contraception History Nexplanon/injectables | 1 Participants | 0 Participants | 1 Participants |
| Contraception History None | 3 Participants | 4 Participants | 7 Participants |
| Contraception History Nuvaring | 1 Participants | 6 Participants | 7 Participants |
| Contraception History Oral contraceptive pill | 6 Participants | 2 Participants | 8 Participants |
| Contraception History Unknown | 3 Participants | 3 Participants | 6 Participants |
| History of Infection Bacterial vaginosis (BV) | 8 Participants | 13 Participants | 21 Participants |
| History of Infection Chlamydia | 0 Participants | 2 Participants | 2 Participants |
| History of Infection Human papillomavirus (HPV) | 6 Participants | 4 Participants | 10 Participants |
| History of Infection None | 7 Participants | 3 Participants | 10 Participants |
| History of Infection Yeast | 4 Participants | 3 Participants | 7 Participants |
| Prior delivery type Cesarean Section | 7 Participants | 4 Participants | 11 Participants |
| Prior delivery type None | 3 Participants | 0 Participants | 3 Participants |
| Prior delivery type Vaginal | 15 Participants | 21 Participants | 36 Participants |
| Race/Ethnicity, Customized African American | 12 Participants | 14 Participants | 26 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Take pain medication | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Pain Score as Assessed by a Visual Analogue Scale
The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
Time frame: about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block | Pain Score as Assessed by a Visual Analogue Scale | 2.1 units on a scale | Standard Deviation 2.5 |
| No Analgesia | Pain Score as Assessed by a Visual Analogue Scale | 2.7 units on a scale | Standard Deviation 2.4 |
p-value: 0.39Fisher Exact
Primary
Pain Score as Assessed by a Visual Analogue Scale
The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
Time frame: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block | Pain Score as Assessed by a Visual Analogue Scale | 2.6 units on a scale | Standard Deviation 2.7 |
| No Analgesia | Pain Score as Assessed by a Visual Analogue Scale | 3.6 units on a scale | Standard Deviation 2.9 |
p-value: 0.23Fisher Exact
Primary
Pain Score as Assessed by a Visual Analogue Scale (VAS)
The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
Time frame: baseline (about 30 seconds after insertion of the speculum)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block | Pain Score as Assessed by a Visual Analogue Scale (VAS) | 2.4 units on a scale | Standard Deviation 2.3 |
| No Analgesia | Pain Score as Assessed by a Visual Analogue Scale (VAS) | 2.1 units on a scale | Standard Deviation 2.4 |
p-value: 0.59Fisher Exact