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Chloroprocaine Spinal for Outpatient Knee Surgery

A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365752
Enrollment
39
Registered
2017-12-07
Start date
2018-06-24
Completion date
2021-02-04
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroscopy

Brief summary

Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while avoiding the side effects of a general anesthetic, thus promoting earlier discharge.

Interventions

DRUGChloroprocaine

A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed

DRUGMepivacaine

A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed

DRUGGeneral Anesthetics

General anesthetics will be administered intravenously

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for a knee arthroscopy that is anticipated to be less than one hour * Age 18 to 80 years * Ability to follow study protocol * English speaking

Exclusion criteria

* Hepatic or renal insufficiency * Younger than 18 years old and older than 80 * Allergy or intolerance to one of the study medications * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Chronic opioid use (taking opioids for longer than 3 months) * Patients unable to undergo a spinal anesthetic or Laryngeal Mask Airway (LMA)/GA or patient refusal to spinal anesthesia or LMA/GA

Design outcomes

Primary

MeasureTime frameDescription
Readiness for DischargeDetermine within 24 hours after surgeryDefined 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Chloroprocaine
Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
13
Mepivacaine
Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
13
General Anesthesia
General Anesthetics: General anesthetics will be administered intravenously
13
Total39

Baseline characteristics

CharacteristicChloroprocaineTotalGeneral AnesthesiaMepivacaine
Age, Continuous49.26 years
STANDARD_DEVIATION 15.87
50.6 years
STANDARD_DEVIATION 13.62
50.65 years
STANDARD_DEVIATION 13.39
51.90 years
STANDARD_DEVIATION 12.34
ASA Physical Status Classification
ASA I - A normal healthy patient
4 Participants9 Participants4 Participants1 Participants
ASA Physical Status Classification
ASA II - A patient with mild systemic disease
9 Participants30 Participants9 Participants12 Participants
Body Mass Index (BMI)27.35 kg/m^2
STANDARD_DEVIATION 4.79
27.99 kg/m^2
STANDARD_DEVIATION 5.25
28.65 kg/m^2
STANDARD_DEVIATION 4.82
27.96 kg/m^2
STANDARD_DEVIATION 6.35
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants38 Participants13 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants5 Participants3 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
White
10 Participants30 Participants7 Participants13 Participants
Sex: Female, Male
Female
4 Participants14 Participants5 Participants5 Participants
Sex: Female, Male
Male
9 Participants25 Participants8 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 130 / 13
other
Total, other adverse events
0 / 130 / 130 / 13
serious
Total, serious adverse events
0 / 130 / 130 / 13

Outcome results

Primary

Readiness for Discharge

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

Time frame: Determine within 24 hours after surgery

ArmMeasureValue (MEAN)Dispersion
ChloroprocaineReadiness for Discharge141.85 minutesStandard Deviation 39.17
MepivacaineReadiness for Discharge174.31 minutesStandard Deviation 38.74
General AnesthesiaReadiness for Discharge170.69 minutesStandard Deviation 67.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026