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=99 Participants
|
26.6 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
25.6 years
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Prior delivery type
Cesarean Section
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prior delivery type
Vaginal
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Prior delivery type
None
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Contraception History
Oral contraceptive pill
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Contraception History
Intrauterine device (IUD)
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Contraception History
Nexplanon/injectables
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Contraception History
Depo Provera/injections
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Contraception History
Condoms (female and male)
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Contraception History
Nuvaring
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Contraception History
None
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Contraception History
Unknown
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
History of Infection
Chlamydia
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
History of Infection
Bacterial vaginosis (BV)
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
History of Infection
Yeast
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
History of Infection
Human papillomavirus (HPV)
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
History of Infection
None
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Take pain medication
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 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