Study Stopped
Inability to recruit subjects at our hospital due to change in surgical patient population. Not worth to continue.
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
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 17, 2015
March 1, 2015
2.4 years
July 11, 2012
March 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Total pain medication
24 hours
Pain scores
24 hours
Study Arms (3)
Placebo
PLACEBO COMPARATORRopivacaine 0.5% plus 2ml of normal saline used for nerve block
Dexamethasone 4 mg
ACTIVE COMPARATORRopivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block
Dexamethasone 8 mg
ACTIVE COMPARATORRopivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block
Interventions
2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
Eligibility Criteria
You may qualify if:
- Ages 18-64
- ASA Physcial Status classification 1-3
- Foot and ankle surgery at Ben Taub General Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ben Taub General Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology
Study Record Dates
First Submitted
July 11, 2012
First Posted
July 16, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03