The Effects of Adding Dexamethasone in the Quadratus Lumborum Block

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Test drug: Name: Dexamethasone sod. Phosphate Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp Dose(s): 4mg Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL Mechanism of action: Synthesis of adrenocortical hormones, has a strong anti-inflammatory effect, can prolong the effect...

Test drug: Name: Dexamethasone sod. Phosphate Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp Dose(s): 4mg Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL Mechanism of action: Synthesis of adrenocortical hormones, has a strong anti-inflammatory effect, can prolong the effect of local anesthetic drugs Pharmacological category: HS051 Glucocorticoids Study design: 1. ? Control: ? placebo?N/S 0.8 mL + 0.25% Ropivacaine 20 mL? active (Dexamethasone 4mg?0.25% Ropivacaine 20 mL) others?N/S 0.8 mL + 0. 5% Ropivacaine 20 mL? ? Uncontrolled 2. Blinding: ? open-label ? single blind ? double blind ? others 3. Randomized: ? yes ? no 4. ? Parallel ? cross-over ? others 5. Duration of study?from Institutional Review Board (IRB) approval ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of treatment?from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months Multi-national ?multi-center(Taiwan) ?single center(Taiwan) 6. Number of subjects: 90 7. Is there any of the followings included Data Safety and Monitoring Board (DSMB) yes ? no Assessment criteria: 1. Efficacy: The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to quantify their degree of pain; where 0 means no pain and 10 the worst pain imaginable. The analgesic activity was assessed using standard measures during the 48-hour treatment period: baseline pain intensity, time to rescue medication, and overall patient evaluation of study medication. 2. Safety: Record the hemodynamic parameters during the 60-minute observation period in the anesthesia recovery room. The severity of postoperative side effects (nausea, vomiting, pruritus) was quantified using different scales. Other side effects, including dizziness and drowsiness, are also recorded. Motor block is assessed using Modified Bromage Scale. 3. Pharmacokinetics: None 4. Quality of life: analgesic activity and duration of action patient satisfaction

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