Trial Outcomes & Findings for Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o (NCT NCT03636451)
NCT ID: NCT03636451
Last Updated: 2023-04-20
Results Overview
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Baseline characteristics by cohort
| Measure |
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 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
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Multiracial
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Induced Abortion vs Early Pregnancy Loss
D&C for Early Pregnancy Loss
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Induced Abortion vs Early Pregnancy Loss
D&C for Induced Abortion
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Once during the procedure on the day of recruitment, approximately one minute. During procedure at time of cervical dilation.Population: Data missing for one participant in the 20cc group because cervical dilation was not performed.
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded at time of cervical dilation. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Outcome measures
| Measure |
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=56 Participants
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Pain With Cervical Dilation
|
52 units on a scale
Interval 35.0 to 62.0
|
45 units on a scale
Interval 29.0 to 64.0
|
SECONDARY outcome
Timeframe: Once during the procedure on the day of recruitment, approximately 1 minute. During procedure immediately after uterine aspiration.Population: Data missing for one participant in the 20cc group because aspiration unable to be performed.
Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded immediately after uterine aspiration. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Outcome measures
| Measure |
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=56 Participants
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Pain With Uterine Aspiration
|
46 units on a scale
Interval 23.0 to 65.0
|
58 units on a scale
Interval 41.0 to 72.0
|
SECONDARY outcome
Timeframe: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded 10 minutes after the completion of the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Outcome measures
| Measure |
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Pain 10 Minutes Post Procedure
|
26 units on a scale
Interval 6.0 to 50.0
|
11 units on a scale
Interval 3.0 to 48.0
|
SECONDARY outcome
Timeframe: Once 10 minutes after the procedure on the day of recruitment, approximately one minute.Distance (mm) from the left of the 100-mm Visual Analog Scale (VAS) (reflecting magnitude of pain) recorded after the procedure reflecting the overall pain felt during the procedure. Pain will be assessed using a 100 mm visual analogue scale with the anchors 0 = none, 100 mm = worst imaginable.
Outcome measures
| Measure |
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 Participants
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Overall Pain
|
57 units on a scale
Interval 50.0 to 65.0
|
56 units on a scale
Interval 48.0 to 76.0
|
Adverse Events
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 participants at risk
20cc 1% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
20cc 1% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block
n=57 participants at risk
40c buffered 0.5% lidocaine with 2 units of vasopressin paracervical block with dilation and curettage under minimal sedation
40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block: Women undergoing D\&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
|
|---|---|---|
|
Nervous system disorders
Minor adverse events
|
26.3%
15/57 • Number of events 15 • From time of consent through clinical discharge time. Approximately 90 minutes.
Serious adverse events: seizure or cardiac arrest. Other non-serious events: minor side effects (transient lightheadedness, tinnitus, circumoral tingling, and a metallic taste in the mouth)
|
21.1%
12/57 • Number of events 12 • From time of consent through clinical discharge time. Approximately 90 minutes.
Serious adverse events: seizure or cardiac arrest. Other non-serious events: minor side effects (transient lightheadedness, tinnitus, circumoral tingling, and a metallic taste in the mouth)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place