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临床试验/NCT04648774
NCT04648774已完成不适用

Continuous Serratus Anterior Blockade for Sternotomy Analgesia Following Cardiac Surgery: A Pilot Feasibility Study.

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Adherence rate

研究概览

简要总结

This is a pilot study to assess the feasibility of a full study. The purpose is to assess the analgesic effectiveness of the serratus anterior plane (SAP) block following cardiac surgery.

Patients will be randomized to receive either Ropivacaine 0.2% or placebo via bilateral SAP block catheters for 72 hours postoperatively.

详细描述

Inadequate pain relief following cardiac surgery increases morbidity, length of stay in the intensive care unit, persistent pain, and costs. Moderate to severe pain is common after cardiac surgery, peaking during the first and second postoperative day, then decreasing after the third day.

Regional anesthesia as part of a multimodal pain management strategy has become a key feature of cardiac surgery enhanced recovery after surgery (ERAS) protocols. A technique consolidating the pectoralis nerve block (PECS) and serratus anterior plane block (SAPB) into a single injection has been described, also called the serratus anterior plane (SAP) block. Given the relative paucity of evidence assessing the utility of continuous serratus anterior plane block (cSAP) in cardiac surgery, we decided to assess the feasibility of a placebo controlled randomized controlled trial (RCT) with a pilot study.

Primary Pilot Study Objective To assess feasibility of a larger intervention study by measuring recruitment rate, adherence rate, retention rates and continuous serratus anterior plane block (cSAP)-related adverse events following cardiac surgery via median sternotomy.

Methods This study will include patients undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG) at the QEII Health Sciences Center in Halifax, Nova Scotia. The study will include a maximum of 50 participants, randomly assigned to 2 study arms of 25 participants. A computer-generated random number will be assigned by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.

cSAP block procedure - Study Intervention A member of the cardiac anesthesia or regional anesthesia team will place bilateral serratus anterior catheters under ultrasound guidance within 2 hours of arrival to the cardiovascular intensive care unit. A bolus of study drug 20ml (either ropivacaine 0.2% or normal saline) will be delivered at the time of the block. A 18g multiholed catheter will be inserted and secured to the patients' skin. The same procedure will be followed on the contralateral side. The study drug will be administered by programmed intermittent bolus (PIB) 10ml every 2 hours to each side in a staggered, alternating fashion. The PIB study drug will to be continued for 72 hours post-insertion.

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 Nova Scotia Health (NSH) pharmacy will prepare either Ropivacaine 0.2% (2mg/ml) or normal saline in identical bags labelled as "study drug" such that the patient, clinical staff and the researchers are blinded to assigned group. The pharmacy will maintain the assignment list, only unmasking assignment in cases of suspected local anesthetic systemic toxicity (LAST) or allergic reactions.

入排标准

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

入选标准

  • Adult (aged >18 years) patients at time of screening
  • Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG)
  • via median sternotomy

排除标准

  • Surgery on an emergency basis (level 1 or 2, <2 hours)
  • An ejection fraction <30%
  • Patient on extracorporeal membrane oxygenator (ECMO),
  • Presence of an intra-aortic balloon pump (IABP)
  • Preoperative vasopressors or inotropes
  • Severe pre-existing liver disease (Child B or C)
  • Severe kidney disease (Glomerular filtration rate (GFR) <30 (mL/min/1·73m²))
  • An allergy to ropivacaine
  • Planned circulatory arrest
  • Weight <50 kg
  • Opioid tolerant (oral morphine equivalent >60mg per day for >1 week prior to admission)
  • Unable to provide valid consent to study prior to surgery

研究组 & 干预措施

Active serratus anterior plane (SAP) block with Ropivacaine 0.2%

Active Comparator

干预措施: Serratus anterior plane (SAP) block (Procedure)

Placebo serratus anterior plane (SAP) block with normal saline

Placebo Comparator

干预措施: Normal saline placebo (Procedure)

结局指标

主要结局

Adherence rate

时间窗: Until measurement of quality of recovery at 72 hours

The number of patients with no protocol violations

Primary outcome measurement rate (quality of recovery 15 index)

时间窗: 72 hours

The number of patients completing the quality of recovery 15 (QoR-15) index

Recruitment rate

时间窗: 1 month

Number of patients recruited to the study

Combined major block-related adverse event rate

时间窗: Until block catheter is removed at 72 hours

The number of patients experiencing a major block-related adverse event including pneumothorax, local anesthetic systemic toxicity (LAST) or allergic reaction.

次要结局

  • Opioid use(24, 48, 72 hours)
  • Quality of recovery 15 index (QoR-15)(48, 72 hours)
  • Pain scores(24, 48, 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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