Chloroprocaine Spinal for Outpatient Knee Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-24

Study Completion Date

2021-02-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Chloroprocaine

Group Type EXPERIMENTAL

Chloroprocaine

Intervention Type DRUG

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

Mepivacaine

Group Type ACTIVE_COMPARATOR

Mepivacaine

Intervention Type DRUG

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

General Anesthesia

Group Type ACTIVE_COMPARATOR

General Anesthetics

Intervention Type DRUG

General anesthetics will be administered intravenously

Interventions

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Chloroprocaine

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

Intervention Type DRUG

Mepivacaine

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

Intervention Type DRUG

General Anesthetics

General anesthetics will be administered intravenously

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No