Trial Outcomes & Findings for Chloroprocaine Spinal for Outpatient Knee Surgery (NCT NCT03365752)

Last Updated: 2022-04-20

Results Overview

Defined as duration from arrival in the post-anesthesia care unit (PACU0 to the time patient meets the discharge criteria from the post anesthesia discharge scoring system (PADSS) for home readiness after ambulatory surgery

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Determine within 24 hours after surgery

Results posted on

2022-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Chloroprocaine Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthesia General Anesthetics: General anesthetics will be administered intravenously
Overall Study STARTED	13	13	13
Overall Study COMPLETED	13	13	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chloroprocaine Spinal for Outpatient Knee Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chloroprocaine n=13 Participants Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine n=13 Participants Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthesia n=13 Participants General Anesthetics: General anesthetics will be administered intravenously	Total n=39 Participants Total of all reporting groups
Age, Continuous	49.26 years STANDARD_DEVIATION 15.87 • n=99 Participants	51.90 years STANDARD_DEVIATION 12.34 • n=107 Participants	50.65 years STANDARD_DEVIATION 13.39 • n=206 Participants	50.6 years STANDARD_DEVIATION 13.62 • n=7 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	14 Participants n=7 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	8 Participants n=107 Participants	8 Participants n=206 Participants	25 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants	13 Participants n=107 Participants	13 Participants n=206 Participants	38 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants	13 Participants n=107 Participants	7 Participants n=206 Participants	30 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Body Mass Index (BMI)	27.35 kg/m^2 STANDARD_DEVIATION 4.79 • n=99 Participants	27.96 kg/m^2 STANDARD_DEVIATION 6.35 • n=107 Participants	28.65 kg/m^2 STANDARD_DEVIATION 4.82 • n=206 Participants	27.99 kg/m^2 STANDARD_DEVIATION 5.25 • n=7 Participants
ASA Physical Status Classification ASA I - A normal healthy patient	4 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	9 Participants n=7 Participants
ASA Physical Status Classification ASA II - A patient with mild systemic disease	9 Participants n=99 Participants	12 Participants n=107 Participants	9 Participants n=206 Participants	30 Participants n=7 Participants

PRIMARY outcome

Timeframe: Determine within 24 hours after surgery

Outcome measures

Outcome measures
Measure	Chloroprocaine n=13 Participants Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine n=13 Participants Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthesia n=13 Participants General Anesthetics: General anesthetics will be administered intravenously
Readiness for Discharge	141.85 minutes Standard Deviation 39.17	174.31 minutes Standard Deviation 38.74	170.69 minutes Standard Deviation 67.9

Adverse Events

Chloroprocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mepivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia

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

Marla Sharp, MPH, MA

Hospital for Special Surgery

Phone: 646-797-8419

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place