Arthroscopic Knee Surgery
Conditions
Brief summary
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
Interventions
PROCEDUREMepivacaine (24 mg) plus fentanyl
Mepivacaine (24 mg) and fentanyl (10 µg)
PROCEDUREMepivacaine (27 mg) plus fentanyl
Mepivacaine (27 mg) and fentanyl (10 µg)
PROCEDUREMepivacaine (30 mg) plus fentanyl
Mepivacaine (30 mg) and fentanyl (10 µg)
PROCEDUREMepivacaine
Mepivacaine 37.5 mg
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects aged 18-60 * Patients scheduled for simple knee arthroscopies, including meniscectomy, debridement, and plica.
Exclusion criteria
* Subjects aged \<18 or \>60 * Subjects greater than 190 cm in height * Patients scheduled for ligament reconstruction or surgery involving bone * Daily use of narcotics for greater than one week pre-op
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. | The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepivacaine 37.5 mg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 22 |
| Mepivacaine 30 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 6 |
| Mepivacaine 27 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 10 |
| Mepivacaine 24 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg) | 18 |
| Total | 56 |
Baseline characteristics
| Characteristic | Mepivacaine 37.5 mg | Mepivacaine 30 mg Plus Fentanyl 10 µg | Mepivacaine 27 mg Plus Fentanyl 10 µg | Mepivacaine 24 mg Plus Fentanyl 10 µg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41 years | 50 years | 46 years | 45 years | 44 years |
| Body Mass Index | 26.3 kg/(m^2) STANDARD_DEVIATION 3.8 | 26.0 kg/(m^2) STANDARD_DEVIATION 4.3 | 28.5 kg/(m^2) STANDARD_DEVIATION 5.6 | 28.7 kg/(m^2) STANDARD_DEVIATION 4.8 | 27.4 kg/(m^2) STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 2 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 8 Participants | 13 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 6 | 0 / 10 | 0 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 6 | 0 / 10 | 0 / 18 |
Outcome results
Primary
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Time frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mepivacaine 37.5 mg | Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | 203 minutes |
| Mepivacaine 30 mg Plus Fentanyl 10 µg | Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | 195 minutes |
| Mepivacaine 27 mg Plus Fentanyl 10 µg | Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | 156 minutes |
| Mepivacaine 24 mg Plus Fentanyl 10 µg | Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) | 159 minutes |