Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
- Conditions
- Shoulder Injury
- Interventions
- Registration Number
- NCT01450007
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Normal saline Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline Dexamethasone block Normal saline Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline Dexamethasone IV Normal saline Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml Dexamethasone block Ropivacaine Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline Placebo Ropivacaine Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline Dexamethasone block Dexamethasone Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline Dexamethasone IV Ropivacaine Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml Dexamethasone IV Dexamethasone Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
- Primary Outcome Measures
Name Time Method Duration of Sensory Blockade Within 48 hours Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
- Secondary Outcome Measures
Name Time Method Post Operative Opioid Dose at 24 Hours approximately 24 hours after surgery Patient Satisfaction With Pain Control 24 hours, 48 hours, 1 week Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.
Time Until First Dose of Analgesic Approximately 10 hours after surgery
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Phoenix, Arizona, United States