Trial Outcomes & Findings for Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation (NCT NCT02852434)
NCT ID: NCT02852434
Last Updated: 2019-06-07
Results Overview
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
Intraoperative; Immediately (0-30 seconds) following cervical dilation
Results posted on
2019-06-07
Participant Flow
Participant milestones
| Measure |
Self-administered Gel
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Self-administered Gel
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Unsuccessful Dilator Procedure
|
2
|
0
|
Baseline Characteristics
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Baseline characteristics by cohort
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 7.14 • n=7 Participants
|
27.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 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
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Gestational Age
|
19 weeks
n=5 Participants
|
19.4 weeks
n=7 Participants
|
19.2 weeks
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative; Immediately (0-30 seconds) following cervical dilationPopulation: Participants who completed the protocol are included in the analysis.
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
|
48.4 units on a scale
Standard Deviation 26
|
56.3 units on a scale
Standard Deviation 29
|
SECONDARY outcome
Timeframe: Preoperative; 30 minutes prior to procedurePopulation: Participants who completed the protocol are included in the analysis.
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Anticipated Pain Measured by Visual Analogue Scale
|
47.2 units on a scale
Standard Deviation 22
|
58.7 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Immediately prior to procedurePopulation: Participants who completed the protocol are included in the analysis
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Baseline Pain Measured by Visual Analogue Scale
|
2.6 units on a scale
Standard Deviation 55
|
6.6 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Intraoperative; Immediately following speculum placementPopulation: Participants who completed the protocol are included in the analysis
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Speculum Placement Measured by Visual Analogue Scale
|
24.7 units on a scale
Standard Deviation 22
|
31.2 units on a scale
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Postoperative; Assessed once 10 minutes after procedurePopulation: Participants who completed the protocol are included in the analysis
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Self-administered Gel
n=34 Participants
Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%)
|
Paracervical Block
n=35 Participants
Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%)
|
|---|---|---|
|
Overall Pain Measured by Visual Analogue Scale
Overall Experience
|
65.2 units on a scale
Standard Deviation 30
|
62.4 units on a scale
Standard Deviation 30
|
|
Overall Pain Measured by Visual Analogue Scale
Overall Pain
|
45.4 units on a scale
Standard Deviation 26.7
|
51.7 units on a scale
Standard Deviation 25.7
|
|
Overall Pain Measured by Visual Analogue Scale
Provider Reported Ease of Insertion
|
27 units on a scale
Standard Deviation 29
|
21 units on a scale
Standard Deviation 22
|
Adverse Events
Self-administered Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paracervical Block
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
Stanford University, Department of OB/GYN
Stanford University Division of Family Planning Services and Research
Phone: 6507211562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place