Chloroprocaine Spinal for Outpatient Knee Surgery

NCT03365752 — Phase 2, Terminated, 39 participants, Hospital for Special Surgery, New York

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A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study

Registry	NCT03365752
Status	Terminated - Study halted due to COVID-19 pandemic and terminated early per request of principal investigator as Chloroprocaine use in spinal procedures has become incorporated as standard of care at HSS.
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	39 (Actual)
Sponsor	Hospital for Special Surgery, New York (Other)
Conditions	Knee Arthroscopy
Interventions	Chloroprocaine, Mepivacaine, General Anesthetics (Drug)
Dates	start 2018-06-24, primary completion 2021-02-04, completion 2021-02-04, first posted 2017-12-07, last updated 2022-04-20
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions
Chloroprocaine	Experimental	Drug: Chloroprocaine
Mepivacaine	Active comparator	Drug: Mepivacaine
General Anesthesia	Active comparator	Drug: General Anesthetics

Chloroprocaine (Drug): A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
Mepivacaine (Drug): A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
General Anesthetics (Drug): General anesthetics will be administered intravenously

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Posted results

Participant flow

Milestone	Chloroprocaine	Mepivacaine	General Anesthesia
Started	13	13	13
Completed	13	13	13
Not completed	0	0	0

Outcome results

Readiness for Discharge (Primary), Mean, minutes: Chloroprocaine 141.85 +/- 39.17; Mepivacaine 174.31 +/- 38.74; General Anesthesia 170.69 +/- 67.9

Adverse events

Time frame: Safety surveillance and reporting starts as soon as the subject undergoes surgery and receives treatment and lasts until the subject concludes their participation in the study or the subject/investigator withdraws the subject from the study. Up to 7 days following surgery.

Arm	Deaths	Serious adverse events	Other adverse events
Chloroprocaine	0/13 (0.0%)	0/13 (0.0%)	0/13 (0.0%)
Mepivacaine	0/13 (0.0%)	0/13 (0.0%)	0/13 (0.0%)
General Anesthesia	0/13 (0.0%)	0/13 (0.0%)	0/13 (0.0%)

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.

+Locations (1)

Facility	City	Country	Status
Hospital for Special Surgery	New York, New York	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2021-02-04)

+Investigators

David Kim, Principal investigator, Hospital for Special Surgery, New York