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Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery

Phase 4
Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboNormal salineBlockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
Dexamethasone blockNormal salineBlockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
Dexamethasone IVNormal salineBlockade 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 blockRopivacaineBlockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
PlaceboRopivacaineBlockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
Dexamethasone blockDexamethasoneBlockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
Dexamethasone IVRopivacaineBlockade 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 IVDexamethasoneBlockade 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
NameTimeMethod
Duration of Sensory BlockadeWithin 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
NameTimeMethod
Post Operative Opioid Dose at 24 Hoursapproximately 24 hours after surgery
Patient Satisfaction With Pain Control24 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 AnalgesicApproximately 10 hours after surgery

Trial Locations

Locations (1)

Mayo Clinic in Arizona

🇺🇸

Phoenix, Arizona, United States

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