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

Baylor College of Medicine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Pain, Sciatic Block

Interventions

PlaceboDRUG

2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block

Dexamethasone 4 mgDRUG

2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Dexamethasone 8 mgDRUG

2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Ben Taub General Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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