Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.

Conditions
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Foot and Ankle Procedures

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone group<br>Dexamethasone 4mg(1 ml) per 20cc | Drug: Dexamethasone<br>* 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc<br>* Other names: Decadron;|
| Placebo Comparator: Saline group<br>Saline 1 ml per 20cc | Drug: Saline<br>* 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 days | 
| Length of Analgesia | Time in days and/or hours | 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 | 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 | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Postoperative opioid requirements, Perioperative outcomes, Dexamethasone, Anesthetic adjuvant, Analgesic adjuvant