Chloroprocaine Spinal for Outpatient Knee Surgery

Phase 2

Terminated

• Conditions: Knee Arthroscopy
• Interventions: Drug: General Anesthetics; Drug: Chloroprocaine; Drug: Mepivacaine

• Registration Number: NCT03365752
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-03
• Study First Posted: 2017-12-07
• Study Start: 2018-06-24
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Results First Submitted: 2021-05-04
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Results First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General Anesthetics	-
Chloroprocaine	Chloroprocaine	-
Mepivacaine	Mepivacaine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States