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

Status: Withdrawn

Conditions: Pain, Sciatic Block

Treatments: Drug: Placebo; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 8 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01641419

H-30398

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Ropivacaine 0.5% plus 2ml of normal saline used for nerve block

Treatment:

Drug: Placebo

Dexamethasone 4 mg

Active Comparator group

Description:

Ropivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block

Treatment:

Drug: Dexamethasone 4 mg

Dexamethasone 8 mg

Active Comparator group

Description:

Ropivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block

Treatment:

Drug: Dexamethasone 8 mg