View Clinical Trial (Medical Research Study)
Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair
| City: |
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Phoenix |
| State: |
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Arizona |
| Zip Code: |
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85259 |
| Conditions: |
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Interscalene Blockade in Elective Arthroscopic Rotator Cuff Repair |
| Purpose: |
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Pre-operative perineural injection of dexamethasone mixed with local anesthetic in
peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of
analgesia, improve visual analog pain scores, decrease post-operative opioid use, and
decrease post-operative nausea. No study has been published to determine if this effect is
a result of systemic absorption of dexamethasone or is a local effect of the drug on
neuronal activity at the injection site. This study is a prospective, randomized,
double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus
intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3)
ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited
sequentially and assigned to the three groups at random in equal ratios. The hypothesis is
that dexamethasone injected perineurally in combination with ropivacaine for interscalene
brachial plexus block will yield longer duration of sensory blockade as compared to
ropivacaine alone without intravenous or perineural dexamethasone and as compared to
ropivacaine and intravenous dexamethasone. This result will suggest that the effect of
dexamethasone is a result of direct neuronal activity at the injection site versus systemic
absorption.
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| Study Summary: |
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| Criteria: |
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Inclusion criteria:
1. Patients are either males or non-pregnant females >/=18 years old undergoing elective
arthroscopic rotator cuff repair by one of two surgeons highly experienced in the
procedure.
2. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to
surgery (tramadol is permissible).
3. Patients have an American Society of Anesthesiology physical status I-III.
Exclusion criteria:
1. Females who are pregnant.
2. Patients who are taking chronic daily opiates for one month prior to surgery except
tramadol.
3. Diabetic patients.
4. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
5. Patients with contralateral pneumothorax or diaphragmatic paralysis.
6. Patients with coagulopathy.
7. Patients with clinically significant previous nerve injury in surgical extremity.
8. Patients with an allergy to NSAIDs.
9. Patients who are refusing a block.
10. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block
due to other medical condition such as severe COPD.
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| NCT ID: |
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NCT01450007 |
| Primary Contact: |
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Principal Investigator
David Rosenfeld, MD
Mayo Clinic
Andre Watkins
Phone: 480-342-0349
Email: watkins.andre@mayo.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Phoenix, Arizona 85259
United States
Andre Watkins
Phone: 480-342-0349
Email: watkins.andre@mayo.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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