Osteoarthritis, Knee
Conditions
Keywords
Anesthesia, Anesthesia, Conduction, Anesthesia, Local, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block, Analgesia, Preanesthetic Medication, Perioperative Period, Peripheral Nerve Block
Brief summary
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
Detailed description
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.
Interventions
DRUGDexamethasone
Used in nerve block mixture
DRUGBupivacaine
Used in nerve block mixture
DRUGEpinephrine
Used in nerve block mixture
PROCEDURESaphenous Peripheral Nerve Block
Peripheral nerve block.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* elective robotic medial MAKO partial knee arthroplasty * agreed to a regional anesthesia technique
Exclusion criteria
* contraindications to regional anesthesia * presence of a progressive neurological deficit * a pre-existing coagulopathy, infection * insulin and non-insulin dependent diabetes mellitus * systemic use of corticosteroids within 30 days of surgery * chronic use of an opioid analgesic (\>3 months or a combined total of more than 40 mg Oxycodone equivalents a day) * pregnancy * a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sensory Nerve Block | 12 to 48 hours | The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Opioid Analgesic Request | 0 to 36 hours | Time it took for the first opioid analgesic request was recorded. |
| Verbal Pain Scores | 0 to 30 hours | Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. |
| Rate of Post Operative Nausea and Vomiting | 0 to 30 hours | Number of participants that experienced nausea and vomiting was recorded. |
| Neurologic Complications | throughout study completion, up to 48 hours | Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. |
| Post Operative Opioid Use and Consumption | 0-30 hours | Amount of opioid use and consumption was recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4 mg Perineural Dexamethasone Group 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block. | 36 |
| 1 mg Perineural Dexamethasone Group 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block. | 36 |
| Placebo Group This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block. | 12 |
| Total | 84 |
Baseline characteristics
| Characteristic | 4 mg Perineural Dexamethasone Group | 1 mg Perineural Dexamethasone Group | Placebo Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 15 Participants | 4 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 8 Participants | 52 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 8.7 | 63.3 years STANDARD_DEVIATION 8.9 | 59.2 years STANDARD_DEVIATION 9.1 | 62.7 years STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants | 36 Participants | 12 Participants | 84 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 9 Participants | 41 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 3 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 12 |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 12 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 12 |
Outcome results
Primary
Duration of Sensory Nerve Block
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
Time frame: 12 to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Duration of Sensory Nerve Block | 37.00 hours | Standard Deviation 11.18 |
| 1 mg Perineural Dexamethasone Group | Duration of Sensory Nerve Block | 31.75 hours | Standard Deviation 10.5 |
| Placebo Group | Duration of Sensory Nerve Block | 29.67 hours | Standard Deviation 6.76 |
Secondary
Neurologic Complications
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
Time frame: throughout study completion, up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Neurologic Complications | 0 neurological complications | Standard Deviation 0 |
| 1 mg Perineural Dexamethasone Group | Neurologic Complications | 0 neurological complications | Standard Deviation 0 |
| Placebo Group | Neurologic Complications | 0 neurological complications | Standard Deviation 0 |
Secondary
Post Operative Opioid Use and Consumption
Amount of opioid use and consumption was recorded.
Time frame: 0-30 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Post Operative Opioid Use and Consumption | 27.16 mg oxycodone equivalents | Standard Deviation 24.35 |
| 1 mg Perineural Dexamethasone Group | Post Operative Opioid Use and Consumption | 26.04 mg oxycodone equivalents | Standard Deviation 24.81 |
| Placebo Group | Post Operative Opioid Use and Consumption | 42.33 mg oxycodone equivalents | Standard Deviation 26.3 |
Secondary
Rate of Post Operative Nausea and Vomiting
Number of participants that experienced nausea and vomiting was recorded.
Time frame: 0 to 30 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 4 mg Perineural Dexamethasone Group | Rate of Post Operative Nausea and Vomiting | 5 Participants |
| 1 mg Perineural Dexamethasone Group | Rate of Post Operative Nausea and Vomiting | 14 Participants |
| Placebo Group | Rate of Post Operative Nausea and Vomiting | 4 Participants |
Secondary
Time to First Opioid Analgesic Request
Time it took for the first opioid analgesic request was recorded.
Time frame: 0 to 36 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Time to First Opioid Analgesic Request | 686.18 minutes | Standard Deviation 420.41 |
| 1 mg Perineural Dexamethasone Group | Time to First Opioid Analgesic Request | 654.97 minutes | Standard Deviation 384.05 |
| Placebo Group | Time to First Opioid Analgesic Request | 658.17 minutes | Standard Deviation 424.66 |
Secondary
Verbal Pain Scores
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.
Time frame: 0 to 30 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 0h | 2.1 units on a scale | Standard Deviation 2.5 |
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 6h | 0.8 units on a scale | Standard Deviation 1.7 |
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 18h | 1.6 units on a scale | Standard Deviation 1.9 |
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 24h | 1.5 units on a scale | Standard Deviation 1.7 |
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 30h | 2.4 units on a scale | Standard Deviation 2.2 |
| 4 mg Perineural Dexamethasone Group | Verbal Pain Scores | 12h | 1.7 units on a scale | Standard Deviation 1.8 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 30h | 3.1 units on a scale | Standard Deviation 2.7 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 0h | 2.3 units on a scale | Standard Deviation 2.5 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 18h | 1.8 units on a scale | Standard Deviation 2.1 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 6h | 1.3 units on a scale | Standard Deviation 2.3 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 24h | 1.8 units on a scale | Standard Deviation 2 |
| 1 mg Perineural Dexamethasone Group | Verbal Pain Scores | 12h | 2.1 units on a scale | Standard Deviation 2.5 |
| Placebo Group | Verbal Pain Scores | 24h | 3.1 units on a scale | Standard Deviation 2 |
| Placebo Group | Verbal Pain Scores | 18h | 3.3 units on a scale | Standard Deviation 2.6 |
| Placebo Group | Verbal Pain Scores | 30h | 4.3 units on a scale | Standard Deviation 2.3 |
| Placebo Group | Verbal Pain Scores | 12h | 3.0 units on a scale | Standard Deviation 2.6 |
| Placebo Group | Verbal Pain Scores | 0h | 2.1 units on a scale | Standard Deviation 2.4 |
| Placebo Group | Verbal Pain Scores | 6h | 1.1 units on a scale | Standard Deviation 2.1 |