Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Total opioid consumption
研究概览
简要总结
Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction.
The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.
The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle.
In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.
详细描述
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 15.0.5 for windows (2017) using previous results with the mean opioid consumption in the first postoperative day as the primary outcome. Effect size of 0.5 (medium effect size) was calculated using the difference between the mean opioid consumption in TAB group (140 mg) and that in ESPB group (124.6 mg) with an estimated standard deviation of 30 in both groups. This study will add a control group in which only intravenous analgesics will be used; hence the aforementioned effect size was used for sample size calculation using a one-way ANOVA test. Sample sizes of 18 patients in each group are needed to achieve 90% power (1-β) to detect differences among the means using an F test with a 0.05 significance level (α). The size of the variation in the means is represented by the effect size f = σm / σ, which is 0.5. A 20% drop out is expected so the drop-out inflated sample size will be 23 patients in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologist grade I-II
排除标准
- •Patient refusal.
- •Local skin infection and sepsis at the site of the block.
- •Allergy to local anesthetic used.
- •Hematological diseases
- •Bleeding disease.
- •Coagulation abnormality.
- •Psychiatric disorders.
结局指标
主要结局
Total opioid consumption
时间窗: For 24 hours after performing block
cumulative consumption of rescue opioids during the first postoperative day
次要结局
- Cortisol level(For one hour after performing block)
- Nausea and vomiting(For 24 hour after surgery)
- Duration of analgesia(for 24 hours after performing block)
- Heart rate(For 24 hours after surgery)
- Peripheral oxygen saturation(For 24 hours after surgery)
- Postoperative visual analogue score(for 24 hours after performing block)
- Mean arterial blood pressure(For 24 hours after surgery)