Chloroprocaine Spinal for Outpatient Knee Surgery

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03365752
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 3
• Actual Duration (Months): 31.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroscopy	Drug: Chloroprocaine; Drug: Mepivacaine; Drug: General Anesthetics	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study
• Actual Study Start Date: Jun 24, 2018
• Actual Primary Completion Date: Feb 4, 2021
• Actual Study Completion Date: Feb 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroprocaine	Drug: Chloroprocaine; A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
Active Comparator: Mepivacaine	Drug: Mepivacaine; A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
Active Comparator: General Anesthesia	Drug: General Anesthetics; General anesthetics will be administered intravenously

Outcome Measures

Primary Outcome Measures

1. Readiness for Discharge [Determine within 24 hours after surgery]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: David Kim, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 4, 2021

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03365752
• Other Study ID Numbers: 2017-1547
• First Posted: Dec 7, 2017
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Anesthetics; Mepivacaine; Chloroprocaine; Anesthetics, General

Study Results

Participant Flow

Arm/Group Title	Chloroprocaine	Mepivacaine	General Anesthesia
Arm/Group Description	Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthetics: General anesthetics will be administered intravenously
Period Title: Overall Study
STARTED	13	13	13
COMPLETED	13	13	13
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Chloroprocaine	Mepivacaine	General Anesthesia	Total
Arm/Group Description	Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthetics: General anesthetics will be administered intravenously	Total of all reporting groups
Overall Participants	13	13	13	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.26 (15.87)	51.90 (12.34)	50.65 (13.39)	50.6 (13.62)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	5 38.5%	5 38.5%	14 35.9%
Male	9 69.2%	8 61.5%	8 61.5%	25 64.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%	0 0%	0 0%	1 2.6%
Not Hispanic or Latino	12 92.3%	13 100%	13 100%	38 97.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	2 15.4%	2 5.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 15.4%	0 0%	3 23.1%	5 12.8%
White	10 76.9%	13 100%	7 53.8%	30 76.9%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.7%	0 0%	1 7.7%	2 5.1%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.35 (4.79)	27.96 (6.35)	28.65 (4.82)	27.99 (5.25)
ASA Physical Status Classification (Count of Participants)
ASA I - A normal healthy patient	4 30.8%	1 7.7%	4 30.8%	9 23.1%
ASA II - A patient with mild systemic disease	9 69.2%	12 92.3%	9 69.2%	30 76.9%

Outcome Measures

1. Primary Outcome

Title	Readiness for Discharge
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Mepivacaine	General Anesthesia
Arm/Group Description	Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	General Anesthetics: General anesthetics will be administered intravenously
Measure Participants	13	13	13
Mean (Standard Deviation) [minutes]	141.85 (39.17)	174.31 (38.74)	170.69 (67.9)

Adverse Events

Time Frame	Safety surveillance and reporting starts as soon as the subject undergoes surgery and receives treatment and lasts until the subject concludes their participation in the study or the subject/investigator withdraws the subject from the study. Up to 7 days following surgery.
Arm/Group Title	Chloroprocaine		Mepivacaine		General Anesthesia
Arm/Group Description	Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed		Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed		General Anesthetics: General anesthetics will be administered intravenously
All Cause Mortality
	Chloroprocaine		Mepivacaine		General Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Chloroprocaine		Mepivacaine		General Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Chloroprocaine		Mepivacaine		General Anesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)

Limitations/Caveats

This project was terminated early, as enrollment was negatively impacted to due to the COVID-19 pandemic and because clinical practice has shifted to include the use of chloroprocaine in spinal procedures as standard of care at the Hospital for Special Surgery.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.