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临床试验/NCT03128346
NCT03128346Unknown不适用

Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study

Western University, Canada1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月1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
发起方
入组人数
100
试验地点
1
主要终点
Narcotic requirements equivalents

研究概览

简要总结

The TTP block is a novel regional anesthetic technique that shows promise in providing analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to show that by providing the TTP block, there will be reduced early postoperative pain, reduced sedation and shallow breathing, reduced time on breathing machine, leading to an increase in patient comfort and satisfaction. The investigators also hope the decreased need for pain medication and reduced time on the breathing machine will translate into decreased nursing workload.

详细描述

In February 2015, Ueshima et al published an article regarding ultrasound guided transversus thoracic muscle plane (TTP) block for breast cancer resection. In this article, he showed that branches of the intercostal nerves (Th2-6) dominate the region of the internal mammary area. By administering local anesthetics between the internal intercostal and transversus thoracic muscle, analgesia in the anterior chest and sternum can be obtained. A cadaveric study shows injectate spread from the second to fifth intercostal spaces with a single 15mL injection between the third and fourth ribs next to the sternum. They further published a case series of two patients who successfully underwent median sternotomy for aortic valve replacement and thymoma resection using only the TTP block for analgesia. Fast- track cardiac surgery is now widely practiced, and evidence for its safety and efficacy has spurred its adoption. With the increased demand for health care resources including nursing manpower and ICU beds, postoperative patients are returning to the cardiac surgery intensive care unit (CSICU) on shorter acting anesthetic agents so that they can be awakened, following commands and spontaneously ventilating earlier. The TTP block fits in well with the fast- track paradigm. By providing adequate analgesia for median sternotomy, the TTP block may reduce narcotic requirements and consequent sedation and respiratory depression, hypercapnia and respiratory acidosis, prolonged mechanical ventilation and need for emergency advanced airway interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will be blinded to the randomization

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

  • patients undergoing cardiac surgical procedures performed by a single conventional median sternotomy, and first case of the day patient because early postoperative pain scores are difficult to obtain overnight for patients admitted to the ICU in the evening.

排除标准

  • patients undergoing non-median sternotomy access, surgeries involving saphenous vein or radial artery harvests, emergency cases, LVEF (Left ventricular efection fraction) <30%, ASAPS (American society of anesthesiologists physical status)=5, known local anesthetic allergy, allergy to any study medications, pre-existing major organ dysfunction including hepatic and renal failure, eGFR (estimated glomerular filtration rate) <60mL/min/1.73m2, coagulopathy, hematological disorders, infection at the site of injection, significant psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression), narcotic dependency (chronic opioid use of greater than 15mg oral morphine equivalents daily), peripheral neuropathy, pregnancy, patient refusal, lack of informed consent, moderate cognitive impairment, and language or reading barrier.

研究组 & 干预措施

The nerve block group

Experimental

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

干预措施: Transthoracic Transversus Plane Block (Procedure)

The nerve block group

Experimental

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

干预措施: Hydromorphone Hydrochloride (Drug)

The nerve block group

Experimental

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

干预措施: Aspirin (Drug)

The nerve block group

Experimental

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

干预措施: Acetaminophen (Drug)

The nerve block group

Experimental

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

干预措施: Fentanyl (Drug)

The standard of care group

Active Comparator

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

干预措施: Hydromorphone Hydrochloride (Drug)

The standard of care group

Active Comparator

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

干预措施: Aspirin (Drug)

The standard of care group

Active Comparator

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

干预措施: Acetaminophen (Drug)

The standard of care group

Active Comparator

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Narcotic requirements equivalents

时间窗: From the time of ICU admission up to 48 hours

The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.

次要结局

  • Time to extubation(From the time of ICU admission up to 24 hours)
  • Patient satisfaction satisfaction(From extubation up to 48 hours)
  • Pain score equivalents(From the time of ICU admission up to 48 hours)
  • Respiratory rate(After extubation up to 48 hours)
  • Oxygen saturation by pulse oximetry(After extubation up to 48 hours)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Satoru Fujii

Clinical fellow

Western University, Canada

研究点 (1)

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