A Phase 2 interventional study of Chloroprocaine and Mepivacaine in Knee Arthroscopy, sponsored by Hospital for Special Surgery, New York. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Hospital for Special Surgery, New York · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Chloroprocaine
Drug: Mepivacaine
Drug: General Anesthetics
A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
General anesthetics will be administered intravenously
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
Time frame: Determine within 24 hours after surgery
| Milestone | Chloroprocaine | Mepivacaine | General Anesthesia |
|---|---|---|---|
| Started | 13 | 13 | 13 |
| Completed | 13 | 13 | 13 |
| Not completed | 0 | 0 | 0 |
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
| minutes | Chloroprocaine | Mepivacaine | General Anesthesia |
|---|---|---|---|
| Readiness for Discharge | 141.85 ± 39.17 | 174.31 ± 38.74 | 170.69 ± 67.9 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chloroprocaine | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Mepivacaine | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| General Anesthesia | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| Mean | 49.26 ± 15.87 | 51.90 ± 12.34 | 50.65 ± 13.39 | 50.6 ± 13.62 |
| Sex: Female, Male(Participants) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| Female | 4 | 5 | 5 | 14 |
| Male | 9 | 8 | 8 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 12 | 13 | 13 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 3 | 5 |
| White | 10 | 13 | 7 | 30 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Body Mass Index (BMI)(kg/m^2) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| Mean | 27.35 ± 4.79 | 27.96 ± 6.35 | 28.65 ± 4.82 | 27.99 ± 5.25 |
| ASA Physical Status Classification(Participants) | Chloroprocaine | Mepivacaine | General Anesthesia | Total |
|---|---|---|---|---|
| ASA I - A normal healthy patient | 4 | 1 | 4 | 9 |
| ASA II - A patient with mild systemic disease | 9 | 12 | 9 | 30 |
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Hospital for Special Surgery, New York