Knee ArthroscopyPhase 2NCT03365752

Chloroprocaine Spinal for Outpatient Knee Surgery

A Phase 2 study testing Chloroprocaine, Mepivacaine and General Anesthetics in people with Knee Arthroscopy, run by Hospital for Special Surgery, New York at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Knee Arthroscopy
What is being tested?: Chloroprocaine, Mepivacaine and General Anesthetics
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2018to 4 Feb 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

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
Being tested: Chloroprocaine, Mepivacaine, General Anesthetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChloroprocaineDrug
A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
MepivacaineDrug
A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
General AnestheticsDrug
General anesthetics will be administered intravenously

Study groups in NCT03365752
Study group	Role	What they receive
Chloroprocaine	Experimental	Not described Receives: Drug: Chloroprocaine
Mepivacaine	Active comparator	Not described Receives: Drug: Mepivacaine
General Anesthesia	Active comparator	Not described Receives: Drug: General Anesthetics

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Determine within 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 20184 Feb 2021

First posted7 Dec 2017
Study start24 Jun 2018
Primary completion4 Feb 2021
Study completion4 Feb 2021

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03365752
Sponsor's protocol ID: 2017-1547
Status last verified: Apr 2022
First submitted: 27 Nov 2017
Last updated: 20 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Arthroscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study
ClinicalTrials.gov ID: NCT03365752
Acronym / sponsor ID: 2017-1547
Conditions: Knee Arthroscopy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 39 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 24 Jun 2018 (actual)
Primary completion: 4 Feb 2021 (actual)
Study completion: 4 Feb 2021 (actual)
First posted: 7 Dec 2017 (actual)
Results: Posted 20 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChloroprocaineA spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed	Drug	Chloroprocaine
MepivacaineA spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed	Drug	Mepivacaine
General AnestheticsGeneral anesthetics will be administered intravenously	Drug	General Anesthesia

Primary outcome

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

Results and safety

Results posted to the registry on 20 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chloroprocaine	13	13
Mepivacaine	13	13
General Anesthesia	13	13

Primary outcome: Readiness for Discharge

Time frame: Determine within 24 hours after surgery. Mean (Standard Deviation). Unit: minutes

Measure	Chloroprocaine n = 13	Mepivacaine n = 13	General Anesthesia n = 13
Value	141.85 (39.17)	174.31 (38.74)	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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chloroprocaine	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Mepivacaine	0 of 13 (0%)	0 of 13 (0%)	0 of 13
General Anesthesia	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Knee Arthroscopy

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Not yet recruitingPhase 4
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Post Operative Swelling
Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Kim principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chloroprocaine, Mepivacaine and General Anesthetics in people with Knee Arthroscopy, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readiness for Discharge (time frame: Determine within 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03365752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.