A Phase 4 interventional study of Dexamethasone and Saline in Foot and Ankle Procedures, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-06.
Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Prevention
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.
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.
Browse Agnosia studies →Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
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Exclusion Criteria:
Dexamethasone 4mg(1 ml) per 20cc
Drug: Dexamethasone
Saline 1 ml per 20cc
Drug: Saline
0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc
Also known as: Decadron
0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Also known as: placebo
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
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
Length of Analgesia
Time in days and/or hours
Time frame: 3 days
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
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
| Milestone | Dexamethasone Group | Saline Group |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 28 |
| Not completed | 2 | 2 |
| Withdrew: Failed block and follow up | 2 | 2 |
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
| Scores on a scale | Dexamethasone Group | Saline Group |
|---|---|---|
| Postoperative Pain | 0.21 ± 0.56 | 0.05 ± 0.22 |
Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)
| Opioids consumption mg | Dexamethasone Group | Saline Group |
|---|---|---|
| Opioid Consumption | 0 ± 0 | 0 ± 0 |
Time in days and/or hours
| Hours | Dexamethasone Group | Saline Group |
|---|---|---|
| Length of Analgesia | 36 (25 to 51) | 30 (22.5 to 41.5) |
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
| Scores on a scale | Dexamethasone Group | Saline Group |
|---|---|---|
| Patient Satisfaction With Regional Nerve Block | 9.6 ± 0.9 | 9.3 ± 1.8 |
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
| Scores on a scale | Dexamethasone Group | Saline Group |
|---|---|---|
| Patient Satisfaction With Pain Management | 9 ± 1.7 | 9.3 ± 1.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Group | — | 0/28 (0%) | 0/28 (0%) |
| Saline Group | — | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Dexamethasone Group | Saline Group | Total |
|---|---|---|---|
| Mean | 55 ± 15 | 55 ± 14 | 55 ± 14 |
| Sex: Female, Male(Participants) | Dexamethasone Group | Saline Group | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 19 | 17 | 36 |
| Race (NIH/OMB)(Participants) | Dexamethasone Group | Saline Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 25 | 25 | 50 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dexamethasone Group | Saline Group | Total |
|---|---|---|---|
| United States | 28 | 28 | 56 |
Plan to share: Yes
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Studies of the drug tested here: Dexamethasone