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Trial Outcomes & Findings for Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal) (NCT NCT02862912)

NCT ID: NCT02862912

Last Updated: 2020-12-24

Results Overview

The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

3 hours

Results posted on

2020-12-24

Participant Flow

Participant milestones

Participant milestones
Measure
Chloroprocaine (CP)
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Bupivacaine (BUP)
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups Saline: Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml
Overall Study
STARTED
23
20
Overall Study
COMPLETED
22
20
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Chloroprocaine (CP)
n=23 Participants
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Bupivacaine (BUP)
n=20 Participants
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups Saline: Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml
Total
n=43 Participants
Total of all reporting groups
Age, Continuous
33 years
STANDARD_DEVIATION 4 • n=93 Participants
34 years
STANDARD_DEVIATION 6 • n=4 Participants
33 years
STANDARD_DEVIATION 5 • n=27 Participants
Sex: Female, Male
Female
23 Participants
n=93 Participants
20 Participants
n=4 Participants
43 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=93 Participants
8 Participants
n=4 Participants
16 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=93 Participants
12 Participants
n=4 Participants
26 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=93 Participants
7 Participants
n=4 Participants
21 Participants
n=27 Participants
Race (NIH/OMB)
White
7 Participants
n=93 Participants
9 Participants
n=4 Participants
16 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants
3 Participants
n=4 Participants
5 Participants
n=27 Participants
Region of Enrollment
United States
23 Participants
n=93 Participants
20 Participants
n=4 Participants
43 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 3 hours

Population: One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed. During analysis it was noted that the motor and sensory block resolution data was missing for 2 subjects in the bupivacaine group so only partial data was available. As a result, 17 participants were analyzed in the bupivacaine group.

The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)

Outcome measures

Outcome measures
Measure
Chloroprocaine (CP)
n=22 Participants
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Bupivacaine (BUP)
n=17 Participants
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups Saline: Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml
Time to Resolution of Motor Block
109 minutes
Interval 88.0 to 148.0
112 minutes
Interval 97.0 to 143.0

SECONDARY outcome

Timeframe: 5 hours

Population: One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed.

Time from spinal anesthesia placement to ability to ambulate.

Outcome measures

Outcome measures
Measure
Chloroprocaine (CP)
n=22 Participants
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Bupivacaine (BUP)
n=19 Participants
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups Saline: Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml
Time to Ambulate
158 minutes
Interval 137.0 to 188.0
229 minutes
Interval 186.0 to 332.0

SECONDARY outcome

Timeframe: 5 hours

Population: In practice, time to void coincided with time to ambulate (to use toilet) and the data is therefore identical to time to ambulate (also time to meet discharge criteria in practice). One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed.

Time from spinal anesthesia injection to ability to void spontaneously.

Outcome measures

Outcome measures
Measure
Chloroprocaine (CP)
n=19 Participants
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Bupivacaine (BUP)
n=22 Participants
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups Saline: Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml
Time to Void
229 minutes
Interval 186.0 to 332.0
158 minutes
Interval 137.0 to 188.0

Adverse Events

Chloroprocaine (CP)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bupivacaine (BUP)

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

Dr. Allison Lee

Columbia University

Phone: 212-305-6494

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place