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临床试验/NCT06205875
NCT06205875招募中不适用

High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.

Jessa Hospital1 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21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)

研究概览

简要总结

This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.

详细描述

During the last two decades, cardiac surgical techniques have changed dramatically. Evidence for good short and long-term outcomes after endovascular and minimally invasive procedures is rising. This shift made it possible to avoid sternotomy and thus facilitating earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. While policies for early extubation and discharge from the hospital have been implemented, the analgesic regimen has not been modified. Opioids remain the standard treatment in the postoperative setting after cardiac surgery despite known side effects such as nausea, constipation and the risk of addiction. Neuraxial anaesthesia techniques, which require fewer opioids in cardiac surgery, have been studied and validated but not yet implemented.

In 2013, the serratus anterior plane (SAP) block was described as a pain relief option for chest surgery. This anaesthesia technique injects local anaesthetics under the serratus muscle and between the latissimus dorsi and serratus anterior using ultrasound. Successful pain relief with this SAP block has been reported in thoracotomy, chest surgery, and rib fractures. In our previous study, we demonstrated a 40% reduction in morphine consumption during the first 24 hours after total endoscopic aortic valve replacement with an SAP block compared to a control group without an SAP block. Lower pain scores were also observed in the SAP group

As such, in this proposed study, we aim to optimise the intensity of the Serratus anterior plane block (SAPB) to decrease opioid requirements further and to encounter more favourable secondary clinical outcome parameters. One strategy to increase the duration of action of plane blocks is injecting higher doses of local anaesthetics. A meta-analysis by De Oliveira et al. on transabdominal plane (TAP)-blocks for abdominal surgery showed a correlation between the local anaesthetic dose and the late block effect, impacting both pain scores and opioid consumption. In a randomised controlled trial by Suresh, a TAP block with bupivacaine 1.25 mcg/kg was compared to a TAP block with bupivacaine 2.5 mcg/kg, revealing a longer duration of analgesia and a lower need for additional analgesics up to 24 hours post-surgery. Moreover, loading doses up to 2mg/kg body weight are recommended for truncal blocks in general, but the mean injected dose in our intervention group was 1.25mg/kg, considering a mean patient body weight of 79.2kg. Notably, a pharmacokinetic study by Maximos and colleagues on an adrenalised bupivacaine mixture after pectointercostal fascial plane block (PIFB) after cardiac surgery showed that, despite injecting 2mcg/kg adrenalised bupivacain, both total and free arterial serum bupivacaine levels were 10-20 times lower than levels associated with neurologic or cardiovascular toxicity in the literature.

In conclusion, we are convinced we can safely improve the late effects of our SAPB compared to our first study by increasing the dose of the local anesthetic injectate.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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)
  • Bodyweight > 50kg
  • EuroScore ii < 3%

排除标准

  • Refusal to participate
  • 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 opioids
  • Chronic use of analgesic antidepressants and/or antiepileptics
  • Use of prohibited medication which possibly interacts with bupivacaine-epinephrine or opioids (mexiletine, ketoconazole, theophylline, IMAO, Digitalis and cimetidine)
  • 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 paracetamol
  • Class 3 obesity (BMI 40 or more)
  • Pregnancy
  • Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, brady-arrhytmias requiring external pacing,...)

研究组 & 干预措施

Intervention group

Experimental

Patients in the intervention group will receive a mixture of high-dose local anesthetic and epinephrine administered via a serratus anterior plane block.

干预措施: High dose serratus anterior plane block (2.4 mg/kg patient ideal body weight) (Procedure)

Intervention group

Experimental

Patients in the intervention group will receive a mixture of high-dose local anesthetic and epinephrine administered via a serratus anterior plane block.

干预措施: PCIA with morphine (Drug)

Control group

Active Comparator

Patients in the control group will receive a serratus anterior plane block with a low dose local anesthetic (based upon our primary trial).

干预措施: Low dose serratus anterior plane block (1.2mg/kg patient ideal body weight) (Procedure)

Control group

Active Comparator

Patients in the control group will receive a serratus anterior plane block with a low dose local anesthetic (based upon our primary trial).

干预措施: PCIA with morphine (Drug)

结局指标

主要结局

Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)

时间窗: 24 hours after block placement

Morphine consumption will be directly read from the PCIA-system after 24 hours

次要结局

  • Bupivacaine dosage(at 30minutes as well as at 1, 2, 4 and 8 hours after block placement)
  • Opioid consumption during predetermined time intervals after surgery(Every 4 hours until 24 hours after placement of the SAP block)
  • Postoperative pain score in rest and on deep respiration(4, 8, 12 and 24 hours after performing the SAP block and at postoperative day 7.)
  • Time to extubation(Throughout study completion, an average of 7 days)
  • Time to first mobilization(Intended at 6 hours after surgery)
  • Postoperative nausea and vomiting (PONV)(24 hours after performing the SAP block at postoperative day 1)
  • ICU length of stay(Until postoperative day 7)
  • Hospital length of stay(Throughout study completion, an average of 7 days)
  • Opioid free patients first 24 postoperative hours(First 24 hours)
  • Overall patient Satisfaction with analgesic therapy(24 hours after performing the SAP block at postoperative day 1.)
  • Constipation(Until postoperative day 7)
  • Pneumonia(Until postoperative day 7)
  • Quality of recovery(At postoperative day 2 and 7)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stessel Björn

Principle investigator

Jessa Hospital

研究点 (1)

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