Trial Outcomes & Findings for Paracervical Block in First Trimester Surgical Abortions (NCT NCT00617097)
NCT ID: NCT00617097
Last Updated: 2017-09-15
Results Overview
100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Paracervical Block With Lidocaine
Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
|---|---|---|
|
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 in First Trimester Surgical Abortions
Baseline characteristics by cohort
| Measure |
Paracervical Block With Lidocaine
n=25 Participants
Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 Participants
Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
25.6 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
gestational age
|
54 days
STANDARD_DEVIATION 10.1 • n=5 Participants
|
57.3 days
STANDARD_DEVIATION 11 • n=7 Participants
|
55.7 days
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
gravidity
1
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
gravidity
2
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
gravidity
3
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
gravidity
4 or greater
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
gravidity
Missing data
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
prior vaginal deliveries
0
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
prior vaginal deliveries
1 or more
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
prior abortions
0
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
prior abortions
1 or more
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
prior abortions
Missing data
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
level of provider performing procedure
resident/fellow
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
level of provider performing procedure
attending
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
institution
Johns Hopkins University
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
institution
Oregon Health and Science University
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
level of menstrual symptoms
easy
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
level of menstrual symptoms
mild cramping, no medications
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
level of menstrual symptoms
over-the-counter medication use
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
expected level of pain during procedure
|
52.2 mm
Standard Deviation 20.8
|
51.7 mm
Standard Deviation 25.4
|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
after speculum insertion
|
33.6 mm
Standard Deviation 23.2
|
32.7 mm
Standard Deviation 26.6
|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
during paracervical block administration
|
50.8 mm
Standard Deviation 23.6
|
46.0 mm
Standard Deviation 24.3
|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
after cervical dilation
|
74.8 mm
Standard Deviation 19.0
|
59.8 mm
Standard Deviation 25.1
|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
immediately after procedure
|
61.5 mm
Standard Deviation 24.6
|
64.3 mm
Standard Deviation 27.4
|
|
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
30 min after procedure
|
21.8 mm
Standard Deviation 22.4
|
17.6 mm
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: end of study (prior to clinic discharge)100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Visual Analogue Scale Regarding Satisfaction Level
|
62.9 mm
Standard Deviation 24.6
|
63.6 mm
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: end of study (upon discharge from facility after procedure)fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
Outcome measures
| Measure |
Paracervical Block With Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Reported Symptoms
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: end of studyOutcome measures
| Measure |
Paracervical Block With Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 Participants
Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Complications
minor
|
1 participants
|
1 participants
|
|
Complications
serious
|
0 participants
|
2 participants
|
Adverse Events
Paracervical Block With Lidocaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Paracervical Block With Ketorolac and Lidocaine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paracervical Block With Lidocaine
n=25 participants at risk
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 participants at risk
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Reproductive system and breast disorders
immediate postoperative hemorrhage
|
0.00%
0/25 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
4.0%
1/25 • Number of events 1 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
|
Reproductive system and breast disorders
repeat procedure
|
0.00%
0/25 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
4.0%
1/25 • Number of events 1 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
Other adverse events
| Measure |
Paracervical Block With Lidocaine
n=25 participants at risk
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
|
Paracervical Block With Ketorolac and Lidocaine
n=25 participants at risk
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
|
|---|---|---|
|
Reproductive system and breast disorders
reported symptoms
|
12.0%
3/25 • Number of events 3 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
0.00%
0/25 • Data collected during study participation (receipt of written informed consent until 2-4 week follow-up by phone or clinic visit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place