Chloroprocaine Spinal for Outpatient Knee Surgery

NCT03365752 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2017-1547
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Chloroprocaine

EXPERIMENTAL

Drug: Chloroprocaine

Mepivacaine

ACTIVE COMPARATOR

Drug: Mepivacaine

General Anesthesia

ACTIVE COMPARATOR

Drug: General Anesthetics

Interventions

Chloroprocaine DRUG

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

Chloroprocaine

Mepivacaine DRUG

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

Mepivacaine

General Anesthetics DRUG

General anesthetics will be administered intravenously

General Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

chloroprocaine; Mepivacaine; Anesthetics, General

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Limitations and 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.

Results Point of Contact

• Title: Marla Sharp, MPH, MA
• Organization: Hospital for Special Surgery

sharpm@hss.edu

646-797-8419

Study Officials

• David Kim

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 7, 2017
• Study Start: June 24, 2018
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: April 20, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)