Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
详细描述
Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double-blind
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status grade I and grade II.
排除标准
- •Patient refusal.
- •Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
- •Hematological diseases, bleeding or coagulation abnormality.
- •Psychiatric diseases.
- •Local skin infection
- •Sepsis at site of the block.
- •Known intolerance to the study drugs.
- •Body Mass Index > 40 Kg/m2
- •contralateral phrenic palsy
- •pneumothorax
- •pneumectomy
- •severe COPD
研究组 & 干预措施
Perineural levobupivacaine with intravenous saline
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.
干预措施: Perineural levobupivacaine (Drug)
Perineural dexamethasone in addition to levobupivacaine
Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.
干预措施: Perineural dexamethasone in addition to levobupivacaine (Drug)
Intravenous dexamethasone with perineural levobupivacaine
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.
干预措施: Intravenous dexamethasone with perineural levobupivacaine (Drug)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: for 24 hour postoperatively
as measured by time to first analgesic requirement.
次要结局
- Onset time of motor block(For 30 min after injecting local anesthic)
- Postoperative heart rate changes(For one hour after admission to the postoperative anesthesia care unit)
- Postoperative peripheral oxygen saturation changes(For one hour after admission to the postoperative anesthesia care unit)
- Intraoperative Heart rate changes(For 3 hours after surgery)
- Duration of motor block(within 24 hours after the surge)
- Intraoperative analgesic consumption(For 3 hours after surgery)
- Onset of Sensory block(For 30 min after injecting local anesthetic)
- Duration of sensory block(within 24 hours after the surgery.)
- Intraoperative Mean arterial blood pressure changes(For 3 hours after surgery)
- Postoperative Mean arterial blood pressure changes(For one hour after admission to the postoperative anesthesia care unit)
- Total analgesic need and the onset of first intravenous analgesia(After transportation of the patient from PACU up to 24 hours postoperative.)
- Patient satisfaction: 2-point scale(first 24 hours postoperatively)
- Pain score(Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.)