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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Arthroscopy
• Intervention / Treatment: Drug: Chloroprocaine; Drug: Mepivacaine; Drug: General Anesthetics

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia	Drug: General Anesthetics; General anesthetics will be administered intravenously
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2018
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 3, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Anesthetics, General; Mepivacaine; Chloroprocaine
• Other Study ID Numbers: 2017-1547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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