Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Opiat consumption
研究概览
简要总结
Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit.
The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids.
Inadequate post-operative pain control can lead to adverse consequences for patients, such as the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as well as adrenergic activation and its consequences in the form of coronary incidents or gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of mobility can result in thrombosis and embolism. These complications affect hospital functioning, which leads to decreased patient satisfaction, a worse reputation for the hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of re-surgeries and re-admissions, and higher costs for care and treatment.
Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4 cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a study of 3 cases. When performed at the level of the T7 transverse process, studies show the potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are mostly case studies done in this field of study, and internationally there is a call for research into the effect of this technique and randomized controlled trials.
The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing ventral hernia repair.
详细描述
Hypothesis, aims and objectives
The postulated nullhypothesis and alternativ hypothesis is:
H0= there is no difference in opioid consumption postoperatively between multimodal analgesia and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard multimodal analgesia and ESPB.
Sample size calculation
Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and in order to show a 50% reduction in rescue opioid consumption after a successful block with 80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied, total of 52 patients. In order to adjust for missing data and protocol violations we decided to include 2 x 30 patients in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization was done through a computer-generated block randomization process (randomization.com) to reduce bias. The block sizes were randomly chosen to 2, 4 and 6. The total patients randomized were 60 patients to account for missing data and protocol violations. A study nurse prepared and placed the notes of study allocation covered with aluminum foil into opaque envelopes. The envelopes were numbered from 1- 70.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria:
- •BMI (body mass index) 18,5 - 40 and weight >65 kg
- •ASA (American Association of Anesthesiologists Classification system for physical status) I-III .
- •Scheduled for elective ventral hernia operation
- •Planned hospital stay >24 hrs
排除标准
- •Allergy to latex, local anesthesia, Non-Steroidal Anti-Inflammatory Drugs or opioids
- •Chronic pain with daily opiate use
- •Patients with severe renal and/or hepatic disease
- •Local infection at the site of injection
- •Systemic infection
- •AV block 2-3
- •Inability to understand written or spoken Norwegian
- •Inability to cooperate
- •Known abuse of alcohol or medication
- •Pregnancy
- •Weight under 65 kg
结局指标
主要结局
Opiat consumption
时间窗: Postoperatively at one hour.
The opioid consumption measured in orale morphine equivalents after one hour postoperatively.
次要结局
- Postopertive nausea(Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.)
- Postoperative sedation(Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.)
- Postoperative pain(Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.)
- Quality of recovery 15(24 hours, 48 hours and 7 days.)