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Pain, Sciatic Block | 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

Pain, Sciatic Block research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain, Sciatic Block

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Placebo2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block

Drug:Dexamethasone 4 mg2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Drug:Dexamethasone 8 mg2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

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

Study Status

Withdrawn

Start Date: July 2012

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Duration of analgesia

Secondary Outcome: Total pain medication

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Baylor College of Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01641419

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