Chloroprocaine Spinal for Outpatient Knee Surgery

Knee Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03365752
• Other study ID #: 2017-1547
• Status: Terminated
• Phase: Phase 2
• Start date: June 24, 2018
• Est. completion date: February 4, 2021

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroscopy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Determine within 24 hours after surgery