Trial Outcomes & Findings for Pain Control for Intrauterine Device Placement Using Paracervical Block (NCT NCT02219308)
NCT ID: NCT02219308
Last Updated: 2019-11-01
Results Overview
Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Moment of IUD insertion
Results posted on
2019-11-01
Participant Flow
Inclusion: Nulliparous women, 18-45, requesting IUD, seen in our clinic from October 2014 through October 2017 Exclusion: pregnancy, diagnosed chronic pain issues, use of pain medication within 6 hours, misoprostol administration within 24 hours, history of prior IUD placement, known contraindications to IUD placement.
Participant milestones
| Measure |
No Paracervical Block (Sham PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives Sham paracervical block with capped needle.
|
Paracervical Block (PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives paracervical block of 18 mL 1% buffered Lidocaine.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
No Paracervical Block (Sham PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives Sham paracervical block with capped needle.
|
Paracervical Block (PCB)
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives paracervical block of 18 mL 1% buffered Lidocaine.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Pain Control for Intrauterine Device Placement Using Paracervical Block
Baseline characteristics by cohort
| Measure |
No Paracervical Block (Sham PCB)
n=31 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
|
Paracervical Block (PCB)
n=33 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
25.45 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Moment of IUD insertionDistance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.
Outcome measures
| Measure |
No Paracervical Block (Sham PCB)
n=31 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
|
Paracervical Block (PCB)
n=33 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
|
|---|---|---|
|
Pain With Intrauterine Device (IUD) Placement
|
54 mm
Interval 33.0 to 75.0
|
33 mm
Interval 10.0 to 56.0
|
SECONDARY outcome
Timeframe: Anticipation of procedure through 5 minutes after IUD placementDistance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.
Outcome measures
| Measure |
No Paracervical Block (Sham PCB)
n=31 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
|
Paracervical Block (PCB)
n=33 Participants
Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
|
|---|---|---|
|
Median Pain Scores for All Time Points
Anticipated Pain
|
51 mm
Interval 30.0 to 70.0
|
58 mm
Interval 48.0 to 68.0
|
|
Median Pain Scores for All Time Points
Baseline Pain
|
0 mm
Interval 0.0 to 2.0
|
0 mm
Interval 0.0 to 2.0
|
|
Median Pain Scores for All Time Points
Speculum Insertion
|
6 mm
Interval 2.0 to 20.0
|
10 mm
Interval 4.0 to 14.0
|
|
Median Pain Scores for All Time Points
Capped Needle or PCB
|
8 mm
Interval 2.0 to 20.0
|
30 mm
Interval 17.0 to 47.0
|
|
Median Pain Scores for All Time Points
Tenaculum placement
|
10 mm
Interval 4.0 to 19.0
|
15 mm
Interval 6.0 to 24.0
|
|
Median Pain Scores for All Time Points
Uterine Sounding
|
47 mm
Interval 24.0 to 65.0
|
30 mm
Interval 8.0 to 43.0
|
|
Median Pain Scores for All Time Points
IUD placement
|
54 mm
Interval 33.0 to 75.0
|
33 mm
Interval 10.0 to 56.0
|
|
Median Pain Scores for All Time Points
5 mins after IUD placement
|
27 mm
Interval 15.0 to 50.0
|
12 mm
Interval 6.0 to 27.0
|
|
Median Pain Scores for All Time Points
Overall pain
|
51 mm
Interval 21.0 to 65.0
|
30 mm
Interval 16.0 to 48.0
|
Adverse Events
No Paracervical Block (Sham PCB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paracervical Block (PCB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place