Trial Outcomes & Findings for Buffered Lidocaine in Paracervical Blocks (NCT NCT03107754)
NCT ID: NCT03107754
Last Updated: 2021-01-05
Results Overview
For the primary outcome, pain immediately after paracervical block injection was measured by a scale. The scale used was the 100-mm visual analog scale. The minimum score was 0 and the maximum score was 100. Higher numbers indicate worse pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Immediately after injection of the paracervical block
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Standard Paracervical Block
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
Buffered Lidocaine Paracervical Block
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
50
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buffered Lidocaine in Paracervical Blocks
Baseline characteristics by cohort
| Measure |
Standard Paracervical Block
n=48 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Lidocaine: Paracervical block will be injected at 4 points at the cervicovaginal junction to decrease pain
|
Buffered Lidocaine Paracervical Block
n=50 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 4 points at the cervicovaginal junction to decrease pain
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 6 • n=5 Participants
|
28 years
STANDARD_DEVIATION 6 • n=7 Participants
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after injection of the paracervical blockFor the primary outcome, pain immediately after paracervical block injection was measured by a scale. The scale used was the 100-mm visual analog scale. The minimum score was 0 and the maximum score was 100. Higher numbers indicate worse pain.
Outcome measures
| Measure |
Standard Paracervical Block
n=48 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
Buffered Lidocaine Paracervical Block
n=50 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
|---|---|---|
|
Injection Pain
|
44.5 units on a scale
Interval 18.25 to 65.0
|
30 units on a scale
Interval 15.25 to 64.5
|
SECONDARY outcome
Timeframe: Immediately after speculum placement, cervical dilation, uterine aspirationPain scores were measured at multiple points throughout the procedure. Pain scores were measured using a 100 mm visual analog scale with 0 being no pain and 100 being the worst pain ever.
Outcome measures
| Measure |
Standard Paracervical Block
n=48 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Lidocaine: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
Buffered Lidocaine Paracervical Block
n=50 Participants
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Lidocaine-Sodium Bicarbonate: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
|
|---|---|---|
|
Pain After Speculum Placement, Cervical Dilation, and Aspiration
After insertion of speculum
|
13 units on a scale
Standard Deviation 20.7
|
17 units on a scale
Standard Deviation 21.85
|
|
Pain After Speculum Placement, Cervical Dilation, and Aspiration
After cervical dilation
|
60.06 units on a scale
Standard Deviation 26.30
|
55 units on a scale
Standard Deviation 29.57
|
|
Pain After Speculum Placement, Cervical Dilation, and Aspiration
After uterine aspiration
|
67.5 units on a scale
Standard Deviation 26.44
|
69 units on a scale
Standard Deviation 28.54
|
Adverse Events
Standard Paracervical Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buffered Lidocaine 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place