Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
Shanghai, China
NCT Number: NCT04714112
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Shanghai, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine
Other names: Dexamethasone Dexamethasone sodium phosphate
Time frame: one day postoperative
from completion of ISB to VAS for pain > 0 ( in hours)
Time frame: one day postoperative
Time from completion of block procedure to first consumption of opioid analgesic (in hours)
Time frame: two days postoperative
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours
Time frame: 7 days postoperative
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Time frame: one day postoperative
Measured on the morning of first day after surgery
Time frame: 7 days postoperative
Number of participants with localized infection at nerve block site
Time frame: 7 days postoperative
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Time frame: 7 days postoperative
Persistent paresthesia, and sensory/motor block at 7 days
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Other
Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study
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