Foot and Ankle Procedures
Conditions
Keywords
Pain management, Postoperative opioid requirements, Perioperative outcomes, Dexamethasone, Anesthetic adjuvant, Analgesic adjuvant
Brief summary
The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.
Interventions
DRUGDexamethasone
0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc
DRUGSaline
0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 60 patients (30 per group) undergoing foot and ankle procedures * Willingness and ability to sign an informed consent document * No allergies to anesthetic or analgesic medications * American Society of Anesthesiologists (ASA)physical status Class I - III * Aged 18-90 years,either sex
Exclusion criteria
* Refusal to participate in the study * Age\<18 or\> 90 years - * Contraindications to regional blockage including but not limited to: * Patient refusal to regional blockade * Infection at the site of needle insertion * Systemic infection * Bleeding diathesis or coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 3 days | Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 3 days | Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) |
| Length of Analgesia | 3 days | Time in days and/or hours |
| Patient Satisfaction With Regional Nerve Block | 3 days | Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied |
| Patient Satisfaction With Pain Management | 3 days | Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Group 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc | 28 |
| Saline Group 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed Block and follow up | 2 | 2 |
Baseline characteristics
| Characteristic | Dexamethasone Group | Total | Saline Group |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 14 | 55 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 50 Participants | 25 Participants |
| Region of Enrollment United States | 28 participants | 56 participants | 28 participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 19 Participants | 36 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Postoperative Pain
Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Group | Postoperative Pain | 0.21 Scores on a scale | Standard Deviation 0.56 |
| Saline Group | Postoperative Pain | 0.05 Scores on a scale | Standard Deviation 0.22 |
Secondary
Length of Analgesia
Time in days and/or hours
Time frame: 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone Group | Length of Analgesia | 36 Hours |
| Saline Group | Length of Analgesia | 30 Hours |
Secondary
Opioid Consumption
Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Group | Opioid Consumption | 0 Opioids consumption mg | Standard Deviation 0 |
| Saline Group | Opioid Consumption | 0 Opioids consumption mg | Standard Deviation 0 |
Secondary
Patient Satisfaction With Pain Management
Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Group | Patient Satisfaction With Pain Management | 9 Scores on a scale | Standard Deviation 1.7 |
| Saline Group | Patient Satisfaction With Pain Management | 9.3 Scores on a scale | Standard Deviation 1.4 |
Secondary
Patient Satisfaction With Regional Nerve Block
Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Group | Patient Satisfaction With Regional Nerve Block | 9.6 Scores on a scale | Standard Deviation 0.9 |
| Saline Group | Patient Satisfaction With Regional Nerve Block | 9.3 Scores on a scale | Standard Deviation 1.8 |