A Phase 4 interventional study of Lidocaine and No analgesia in Analgesia and IUD Insertion, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
Drug: Lidocaine · Device: Intrauterine device (IUD)
IUD placement with no analgesia.
Other: No analgesia · Device: Intrauterine device (IUD)
Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
Also known as: xylocaine, lignocaine
IUD placement without analgesia.
IUD placement with or without paracervical block with 1% lidocaine.
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)
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)
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)
| Milestone | Paracervical Block | No Analgesia |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
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).
| units on a scale | Paracervical Block | No Analgesia |
|---|---|---|
| Pain Score as Assessed by a Visual Analogue Scale (VAS) | 2.4 ± 2.3 | 2.1 ± 2.4 |
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).
| units on a scale | Paracervical Block | No Analgesia |
|---|---|---|
| Pain Score as Assessed by a Visual Analogue Scale | 2.1 ± 2.5 | 2.7 ± 2.4 |
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).
| units on a scale | Paracervical Block | No Analgesia |
|---|---|---|
| Pain Score as Assessed by a Visual Analogue Scale | 2.6 ± 2.7 | 3.6 ± 2.9 |
Collected over From time of speculum placement until the patient left the office (patient leaves office about 3-5 minutes after the procedure, for a total of about 15 minutes from speculum placement to leaving the office).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paracervical Block | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| No Analgesia | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Mean | 24.6 ± 4.6 | 26.6 ± 5.9 | 25.6 ± 5.4 |
| Sex: Female, Male(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Female | 25 | 25 | 50 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| African American | 12 | 14 | 26 |
| Caucasian | 3 | 3 | 6 |
| Hispanic | 7 | 7 | 14 |
| Asian | 1 | 0 | 1 |
| Unknown | 2 | 1 | 3 |
| Region of Enrollment(participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
| Prior delivery type(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Cesarean Section | 7 | 4 | 11 |
| Vaginal | 15 | 21 | 36 |
| None | 3 | 0 | 3 |
| Contraception History(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Oral contraceptive pill | 6 | 2 | 8 |
| Intrauterine device (IUD) | 1 | 5 | 6 |
| Nexplanon/injectables | 1 | 0 | 1 |
| Depo Provera/injections | 7 | 3 | 10 |
| Condoms (female and male) | 3 | 2 | 5 |
| Nuvaring | 1 | 6 | 7 |
| None | 3 | 4 | 7 |
| Unknown | 3 | 3 | 6 |
| History of Infection(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Chlamydia | 0 | 2 | 2 |
| Bacterial vaginosis (BV) | 8 | 13 | 21 |
| Yeast | 4 | 3 | 7 |
| Human papillomavirus (HPV) | 6 | 4 | 10 |
| None | 7 | 3 | 10 |
| Take pain medication(Participants) | Paracervical Block | No Analgesia | Total |
|---|---|---|---|
| Count of participants | 2 | 2 | 4 |
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The University of Texas Health Science Center, Houston