Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

Study Overview
=================
Brief Summary
-----------------
The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.

Official Title
-----------------
Randomized, Controlled Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

Conditions
-----------------
Pain, Sciatic Block

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dexamethasone 4 mg
* Drug: Dexamethasone 8 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-64 ASA Physcial Status classification 1-3 Foot and ankle surgery at Ben Taub General Hospital Exclusion Criteria: diabetes mellitus peripheral neuropathy coagulopathy allergy to study drugs systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery chronic opioid use at home patient inability to properly describe pain to investigators pregancy prisoners patient or surgeon refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Ropivacaine 0.5% plus 2ml of normal saline used for nerve block | Drug: Placebo<br>* 2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block<br>|
| Active Comparator: Dexamethasone 4 mg<br>Ropivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block | Drug: Dexamethasone 4 mg<br>* 2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block<br>|
| Active Comparator: Dexamethasone 8 mg<br>Ropivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block | Drug: Dexamethasone 8 mg<br>* 2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | Duration of analgesia of popliteal fossa sciatic nerve block defined as time of first pain as described by patient minus time of block placement in minutes | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pain medication | Total amounts of morphine, fentanyl and hydrocodone/acetaminophen that the patient required for pain control during first 24 hours after surgery. All patients, regardless of group, will receive a standardized postoperative pain medication regimen which will include hydrocodone/acetaminophen tablets primarily, and morphine/fentanyl as needed. | 24 hours | 
| Pain scores | Pain score measured of numeric analog scale from 0-10 during first 24 hours measures and 0,1,2,4,8,12, and 24 hours after surgery. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Ropivacaine, sciatic block, dexamethasone