Trial Outcomes & Findings for Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery (NCT NCT03760718)
NCT ID: NCT03760718
Last Updated: 2024-09-19
Results Overview
The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
1 minute after intraperitoneal chloroprocaine administration
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Preservative Free Chloroprocaine Group 1
40 ml of preservative-free 1% chloroprocaine administered into the peritoneal cavity after delivery of the baby
|
Preservative Free Chloroprocaine Group 2
40 ml of preservative-free 2% chloroprocaine administered into the peritoneal cavity after delivery of the baby
|
Preservative Free Chloroprocaine Group 3
40 ml of preservative-free 3% chloroprocaine administered into the peritoneal cavity after delivery of the baby
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
34 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
American Society of Anesthesiologists Physical Status
American Society of Anesthesiologists Physical Status 2
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
American Society of Anesthesiologists Physical Status
American Society of Anesthesiologists Physical Status 3
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 minute after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Chloroprocaine Plasma Concentration at 1 Minute
|
14.3 ng/ml
Interval 0.4 to 39.9
|
7.5 ng/ml
Interval 1.0 to 16.6
|
3.5 ng/ml
Interval 1.1 to 6.0
|
PRIMARY outcome
Timeframe: 5 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Chloroprocaine Plasma Concentration at 5 Minutes
|
14.5 ng/ml
Interval 4.1 to 24.7
|
14.1 ng/ml
Interval 4.7 to 24.0
|
323.1 ng/ml
Interval 34.8 to 611.4
|
PRIMARY outcome
Timeframe: 10 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Chloroprocaine Plasma Concentration at 10 Minutes
|
10.4 ng/ml
Interval 5.8 to 15.1
|
6.0 ng/ml
Interval 1.1 to 10.8
|
217.9 ng/ml
Interval 11.0 to 606.3
|
PRIMARY outcome
Timeframe: 20 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Chloroprocaine Plasma Concentration at 20 Minutes
|
2.2 ng/ml
Interval 0.5 to 4.4
|
1.7 ng/ml
Interval 1.0 to 2.7
|
3.4 ng/ml
Interval 0.7 to 7.8
|
PRIMARY outcome
Timeframe: 30 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Chloroprocaine Plasma Concentration at 30 Minutes
|
3.4 ng/ml
Interval 0.2 to 9.1
|
1.2 ng/ml
Interval 0.5 to 2.3
|
3.1 ng/ml
Interval 0.6 to 5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 hours of intraperitoneal chloroprocaine administrationdescription of dizziness upon research coordinator query
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 4 hours of study drug administrationdescription of metallic taste upon research coordinator query
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Metallic Taste
|
0 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 hours of study drug administrationdescription of nausea upon research coordinator query
Outcome measures
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 Participants
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 Participants
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 Participants
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Nausea
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Preservative Free Chloroprocaine Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Preservative Free Chloroprocaine Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Preservative Free Chloroprocaine Group 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preservative Free Chloroprocaine Group 1
n=5 participants at risk
40 ml of preservative-free 1% chloroprocaine
Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 2
n=5 participants at risk
40 ml of preservative-free 2% chloroprocaine
Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
Preservative Free Chloroprocaine Group 3
n=5 participants at risk
40 ml of preservative-free 3% chloroprocaine
Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
|
|---|---|---|---|
|
Nervous system disorders
dizziness
|
20.0%
1/5 • Number of events 1 • 1 day
|
0.00%
0/5 • 1 day
|
0.00%
0/5 • 1 day
|
|
Nervous system disorders
metallic taste
|
0.00%
0/5 • 1 day
|
20.0%
1/5 • Number of events 1 • 1 day
|
0.00%
0/5 • 1 day
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5 • 1 day
|
20.0%
1/5 • Number of events 1 • 1 day
|
20.0%
1/5 • Number of events 1 • 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place