2023-508719-22-00招募中4 期
High versus low dose serratus anterior plane block after minimally invasive valve surgery: a double-blinded randomized controlled trial
Jessa Ziekenhuis1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.
研究概览
简要总结
We hypothesize a 25% reduction in opioid consumption in patients randomized to the high dose local anesthesia intervention arm towards patients in the control arm.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy
- •Adult patients (minimally 18 years old)
- •EuroScore ii < 3%
排除标准
- •Refusal to participate
- •Class 3 obesity (BMI 40 or more)
- •Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)
- •Inability to communicate due to language or neurologic barriers
- •Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties
- •Chronic use of analgesic antidepressants and/or antiepileptics
- •Chronic use of opioids
- •History of major trauma or surgery to right chest wall
- •History of chronic pain at right chest wall
- •Allergy to opioids and/or local anesthetics
- •Allergy to acetaminophen
结局指标
主要结局
Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.
Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.
次要结局
- The postoperative pain on the surgical site is evaluated based on a 11-points numeric scale (Numerical Rating Sale - NRS) where 0 = no pain and 10 = worst pain ever. The NRS pain score in rest as well as with deep respiration is assessed at 4 hours, 8 hours, 12 hours and 24 hours after performing the Serratus Anterion Plane Block and at POD 7.
- Overall patient satisfaction with analgesic therapy will be assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied) 24h after performing the Serratus Anterior Plane Block at POD 1.
- Time from arrival to the ICU until extubation in minutes.
- Time from arrival to the ICU until first mobilization. According to our ERACS protocol, active patient mobilization is intended at six hours after surgery on the conditions that patients are extubated, chest tube drainage is low (<50ml/h) and patients are comfortable.
- The simplified PONV impact scale will be used to assess PONV 24h after performing the SAP block at POD 1. Clinically important PONV will be defined as a score of 5 or more.
- Time to first defecation (postoperative days) or need for laxatives during hospital stay (number of patients)
- Time from arrival to the ICU until meeting discharge criteria to the ward in postoperative hours.
- Time to discharge out of the hospital in postoperative days (day of surgery = day 0)
- Pneumonia defined as empirical antibiotic therapy for suspicion of pneumonia during hospital stay, in number of patients.
- Serum bupivacaine levels have never been recorded after SAPB. In the first 36 study patients, arterial blood samples will be taken at 30minutes as well as at 1, 2, 4 and 8 hours after block placement for dosage of total and free plasma bupivacaine levels.
- Quality of recovery will be assessed at POD 2 and POD 7 with Quality of Life questionnaires: EQ5D and short form health survey (SF-36).
- Opioid consumption will be evaluated at predetermined time intervals after performing the Serratus anterior plane block (0-4h, 4-8h, 8-12h, 12-16h, 16-20h, and 20-24h)
- Number of patients that do not require any additional PCIA opioids within the first 24 hours after block placement.
研究者
Bjorn Stessel
Scientific
Jessa Ziekenhuis
研究点 (1)
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