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The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane

2022年5月23日 更新者:University of Alberta

Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient by minimizing the opioid usage after surgery and also reduce cost to the system in terms of duration of hospital stay. The purpose of the study is to investigate whether the inclusion of a nerve block to the general anesthetic for rotator cuff repair surgery will also reduce the amount of inhaled anesthetic and thereby lowering the environmental footprint from the anesthetic.

The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve block is applied before or after surgery. Patients will have a nerve block catheter (interscalene catheter) placed under ultrasound-guidance prior to the induction of general anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or normal saline (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and the total amount of volatile anesthetic (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or local anesthetic before the patient is woken up.

研究概览

详细说明

Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:

Interscalene nerve block catheter insertion with 20 mL 0.5% ropivacaine injection (Treatment group) Interscalene nerve block catheter insertion with 20 mL normal saline injection (Sham group)

The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. The patients consenting for the study and meeting the eligibility criteria for the study will be randomized to either group-1 (PRE-GA) or group-2 (POST-GA) . Prior to induction of general anesthesia, all patients will receive an interscalene nerve block catheter (Pajunk e-cath) inserted under ultrasound guidance using the catheter-over-needle technique by an acute pain physician who has been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by ultrasound visualization of the injectate spread. Based on the randomization, each patient will receive a clear 10 mL syringe containing either the Treatment or the Sham solution. Patients in group PRE-GA will receive 10 ml of 0.5% ropivacaine through the catheter before the start of surgery and 10 ml of saline (0.9%) at the end of surgery. The patients in group POST-GA will receive 10 ml of saline (0.9%) before the start of surgery and 10 ml of 0.5% ropivacaine at the end of surgery. All study medications will be prepared by the principal investigator who will be unblinded to the patient allocation. All other team members will be blinded to the group allocation.

Following the interscalene nerve block catheter insertion, all patients will receive general anesthesia with a standardized protocol using intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) if the Patient State Index (PSI) is >50 and/or the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.

Postoperatively, patients will be transferred to recovery area where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU to document the success of the block in both groups by the nurses blinded to the group allocation. The Visual Analogue Pain Scale for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. Postoperative opioid consumption, nausea and vomiting scores and pan scores over the first 24 postoperative hours will also be collected for comparison.

研究类型

介入性

注册 (实际的)

27

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alberta
      • Edmonton、Alberta、加拿大、T6G2G3
        • University of Alberta Hospital
      • St. Albert、Alberta、加拿大、T8N6C4
        • Sturgeon Community Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients undergoing elective shoulder arthroscopy
  • Patients eligible for interscalene brachial plexus block
  • All adults > 18 years of age
  • Capable to give consent

Exclusion Criteria:

  • Patients who are unable to give consent
  • Local anaesthetic allergy
  • Hemidiaphragm paresis on the contralateral side to the block/surgery site
  • Bleeding diathesis
  • Coagulopathy
  • Pre-existing neurological deficits
  • Patients with a Body Mass Index >35
  • Patients with significant comorbidities, physiological limitations, and allergies that are unable to tolerate the protocolized induction and maintenance of anesthesia.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:PRE-GA
10 mL of 0.5% ropivacaine injection before the start of surgery and 10 ml of normal saline (0.9%) injection at the end of surgery through the interscalene catheter
局麻药注射
Sham injection
假比较器:POST-GA
10 ml of normal saline (0.9%) injection before the start of surgery and 0.5% ropivacaine injection at the end of surgery through the interscalene catheter
局麻药注射
Sham injection

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Average age-adjusted MAC of sevoflurane
大体时间:Intra-operative measurement done at the end of anesthetic
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
Intra-operative measurement done at the end of anesthetic

次要结果测量

结果测量
措施说明
大体时间
Sevoflurane consumption in ml/hr
大体时间:Intra-operative - measurement done at the end of anesthetic
Total amount of Sevoflurane consumed during the intraoperative period will be measured and compared between the two groups
Intra-operative - measurement done at the end of anesthetic
Sevoflurane consumption in ml//kg/hr
大体时间:Intra-operative - measurement done at the end of anesthetic
Total amount of Sevoflurane consumed/kg of patient body weight during the intraoperative period will be measured and compared between the two groups
Intra-operative - measurement done at the end of anesthetic
Intraoperative hemodynamics
大体时间:Intraoperative period
Intraoperative heart rate (in beats/minute), systolic, diastolic and mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups
Intraoperative period
术中使用阿片类药物
大体时间:术中时期
根据研究方案,术中使用短效阿片类药物(微克/千克)将被记录并在两组之间进行比较
术中时期
Postoperative opioid use in PACU
大体时间:24 postoperative hours
Total amount of opioids (in mg of morphine equivalents) in the PACU and over the first 24 postoperative hours will be recorded and compared between the two groups
24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
大体时间:24 postoperative hours
Maximum pain scores will be recorded using numerical rating scale (NRS) of 0-10 (where 0=no pain and 10= maximum pain) on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and compared between the two groups
24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
大体时间:24 postoperative hours
Nausea scores (on a Likert scale of 1-4 where 1 = no nausea, 2= mild nausea, 3= moderate nausea and 4= severe nausea) and incidence of vomiting will be recorded on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and will be compared between the two groups
24 postoperative hours
24 hour opioid consumption
大体时间:24 postoperative hours
Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
24 postoperative hours
PACU 中的镇静评分
大体时间:术后第一小时
根据 Ramsay 镇静量表 (1-6) 每隔 15 分钟记录一次镇静分数,并将在两组之间进行比较
术后第一小时
Block success
大体时间:1st postoperative hour
Sensory testing of the C5 and C6 dermatomes will be performed in the PACU at 30 minutes of arrival to PACU to document the success of the block
1st postoperative hour
术中使用升压药
大体时间:术中时期
将记录术中血管加压药(以微克为单位的去氧肾上腺素)的使用量和频率,并在两组之间进行比较
术中时期

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Vivian HY Ip, MD、University of Alberta
  • 首席研究员:Timur JP Özelsel, MD、University of Alberta
  • 学习椅:Rakesh V Sondekoppam, MD、University of Alberta

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年5月1日

初级完成 (实际的)

2022年1月1日

研究完成 (实际的)

2022年1月1日

研究注册日期

首次提交

2018年4月9日

首先提交符合 QC 标准的

2018年5月10日

首次发布 (实际的)

2018年5月23日

研究记录更新

最后更新发布 (实际的)

2022年5月24日

上次提交的符合 QC 标准的更新

2022年5月23日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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