Trial Outcomes & Findings for Paracervical Block Versus No Paracervical Block During IUD Insertion (NCT NCT02904915)
NCT ID: NCT02904915
Last Updated: 2018-11-07
Results Overview
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).
COMPLETED
PHASE4
50 participants
baseline (about 30 seconds after insertion of the speculum)
2018-11-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paracervical Block Versus No Paracervical Block During IUD Insertion
Baseline characteristics by cohort
| Measure |
Paracervical Block
n=25 Participants
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.
|
No Analgesia
n=25 Participants
IUD placement with no analgesia.
No analgesia: IUD placement without analgesia.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.6 years
STANDARD_DEVIATION 4.6 • n=93 Participants
|
26.6 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
25.6 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Prior delivery type
Cesarean Section
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Prior delivery type
Vaginal
|
15 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Prior delivery type
None
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Contraception History
Oral contraceptive pill
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Contraception History
Intrauterine device (IUD)
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Contraception History
Nexplanon/injectables
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Contraception History
Depo Provera/injections
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Contraception History
Condoms (female and male)
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Contraception History
Nuvaring
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Contraception History
None
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Contraception History
Unknown
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
History of Infection
Chlamydia
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
History of Infection
Bacterial vaginosis (BV)
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
History of Infection
Yeast
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
History of Infection
Human papillomavirus (HPV)
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
History of Infection
None
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Take pain medication
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Paracervical Block
n=25 Participants
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.
|
No Analgesia
n=25 Participants
IUD placement with no analgesia.
No analgesia: IUD placement without analgesia.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine.
|
|---|---|---|
|
Pain Score as Assessed by a Visual Analogue Scale (VAS)
|
2.4 units on a scale
Standard Deviation 2.3
|
2.1 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Paracervical Block
n=25 Participants
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.
|
No Analgesia
n=25 Participants
IUD placement with no analgesia.
No analgesia: IUD placement without analgesia.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine.
|
|---|---|---|
|
Pain Score as Assessed by a Visual Analogue Scale
|
2.1 units on a scale
Standard Deviation 2.5
|
2.7 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)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).
Outcome measures
| Measure |
Paracervical Block
n=25 Participants
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.
|
No Analgesia
n=25 Participants
IUD placement with no analgesia.
No analgesia: IUD placement without analgesia.
Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine.
|
|---|---|---|
|
Pain Score as Assessed by a Visual Analogue Scale
|
2.6 units on a scale
Standard Deviation 2.7
|
3.6 units on a scale
Standard Deviation 2.9
|
Adverse Events
Paracervical Block
No Analgesia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pamela D. Berens, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place