Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks

Study Overview
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Brief Summary
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Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.

Detailed Description
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Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect   6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.

Official Title
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Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study

Conditions
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Analgesia, Dexamethasone, Brachial Plexus Block, Intravenous Drug Usage, Time, Shoulder Surgery

Intervention / Treatment
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* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital. ASA functional status class I to II Age 18 to 70 years BMI ≤ 35 kg/m2 Exclusion Criteria: Lack of patient consent Allergy to dexamethasone or ropivacaine BMI > 35 kg/m2 Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection Pregnant or nursing females Chronic opioid use defined as > 30mg oral morphine or equivalent per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative group<br>Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed. | Drug: dexamethasone<br>* Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine<br>* Other names: Dexamethasone Dexamethasone sodium phosphate;|
| Active Comparator: postoperative group<br>Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU) | Drug: dexamethasone<br>* Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine<br>* Other names: Dexamethasone Dexamethasone sodium phosphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | from completion of ISB to VAS for pain > 0 ( in hours) | one day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Opioid Consumption | Time from completion of block procedure to first consumption of opioid analgesic (in hours) | one day postoperative | 
| Opioid Consumption | Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours | two days postoperative | 
| Visual Analog Scale for pain ( from 0 to 10 ) | Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better. | 7 days postoperative | 
| Postoperative Serum Blood Glucose | Measured on the morning of first day after surgery | one day postoperative | 
| Infection | Number of participants with localized infection at nerve block site | 7 days postoperative | 
| Number of Participants With Postoperative Nausea and/or Vomiting | Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively | 7 days postoperative | 
| Number of Participants With Nerve Damage From Interscalene Block | Persistent paresthesia, and sensory/motor block at 7 days | 7 days postoperative |