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Trial record 8 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Chloroprocaine Outpatient

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ClinicalTrials.gov Identifier: NCT03365752
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Arthroscopy Drug: Chloroprocaine Drug: Mepivacaine Drug: General Anesthetics Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study
Actual Study Start Date : June 24, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Active Comparator: General Anesthesia Drug: General Anesthetics
General anesthetics will be administered intravenously




Primary Outcome Measures :
  1. Readiness for discharge [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365752


Contacts
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Contact: David Kim, MD 212 774 2602 kimd@hss.edu
Contact: Nicole Brunetti, BS 6467146794 brunettin@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: David Kim, MD    646-714-6794    kimd@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: David Kim Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03365752     History of Changes
Other Study ID Numbers: 2017-1547
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Anesthetics
Mepivacaine
Chloroprocaine
Procaine
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents