Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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.

Last updated:

2/20/2014

NCT ID:

NCT01450007

IRB Number:

11-001266