Trial Outcomes & Findings for Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage (NCT NCT03305575)
NCT ID: NCT03305575
Last Updated: 2020-08-25
Results Overview
The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
6 hours
Results posted on
2020-08-25
Participant Flow
Participant milestones
| Measure |
Chloroprocaine
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Chloroprocaine
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Chloroprocaine
n=5 Participants
Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
Chloroprocaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
|
Bupivacaine
n=5 Participants
Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
Bupivacaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
29 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
31 years
STANDARD_DEVIATION 4.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
30.4 Kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
29.7 Kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
30 Kg/m^2
STANDARD_DEVIATION 5.4 • n=10 Participants
|
|
ASA
|
2.3 Scores on a scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
2 Scores on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
2.1 Scores on a scale
STANDARD_DEVIATION 0.38 • n=10 Participants
|
|
Gestational age
|
16 weeks
STANDARD_DEVIATION 3.9 • n=5 Participants
|
14.8 weeks
STANDARD_DEVIATION 3.7 • n=5 Participants
|
15.4 weeks
STANDARD_DEVIATION 3.7 • n=10 Participants
|
PRIMARY outcome
Timeframe: 6 hoursThe time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block
Outcome measures
| Measure |
Chloroprocaine
n=4 Participants
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
n=5 Participants
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Duration of Motor Block
|
75 minutes
Standard Deviation 5.7
|
99 minutes
Standard Deviation 48.0
|
SECONDARY outcome
Timeframe: 6 hoursThe time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.
Outcome measures
| Measure |
Chloroprocaine
n=4 Participants
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
n=5 Participants
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Duration of Sensory Block
|
127 minutes
Standard Deviation 20.6
|
210 minutes
Standard Deviation 56.1
|
SECONDARY outcome
Timeframe: 6 hoursThe time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Outcome measures
| Measure |
Chloroprocaine
n=4 Participants
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
n=5 Participants
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Time to Ambulation
|
110 minutes
Standard Deviation 1.4
|
179 minutes
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6 hoursThe time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
Outcome measures
| Measure |
Chloroprocaine
n=4 Participants
Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
|
Bupivacaine
n=5 Participants
Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
|
|---|---|---|
|
Time to Micturation
|
111 minutes
Standard Deviation 1.3
|
233 minutes
Standard Deviation 1.7
|
Adverse Events
Chloroprocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
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