Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Total opioid consumption
研究概览
简要总结
The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:
- How will the total perioperative opioid consumption of the patients receiving RINB change?
- How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
- How will RINB effect the postoperative extubation times?
- How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
- How will RINB effect the incidence of opioid related side effects?
Participants will be divided in two groups:
- Block group will receive a RINB before the surgery.
- Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery.
The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.
详细描述
Rhomboid intercostal nerve block (RINB) was first defined by Elsharkawy et al in 2016 proposing to provide analgesia for both the anterior and posterior hemithorax. Minimal invasive heart surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing MIHS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. This study aims to assess the analgesic efficacy of RINB for MIHS. The hypothesis is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores, respiratory parameters and ICU length of stay of the participants will be recorded. Participants will be divided in two groups. The block-group will receive a RINB preoperatively in the operating room. The control-group will not receive any nerve block. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, postoperative extubation times, length of ICU stays, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 18-80 undergoing minimal invasive heart surgery
排除标准
- •Allergy to local anaesthetics
- •Chronic opioid use history
- •Patients with psychiatric disorders
- •Patients who are not open to communication
- •Patients with chronic organ failure
- •Patients that do not give consent
- •Patients that need emergency surgery within the first 24 hours of the initial surgery
研究组 & 干预措施
Block group
Participants who will be receiving a rhomboid intercostal nerve block
干预措施: Rhomboid Intercostal Nerve Block (Procedure)
Control group
Participant who will not be receiving any intervention
结局指标
主要结局
Total opioid consumption
时间窗: 24 hours post-surgery
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
次要结局
- Extubation time after surgery(24 hours post-surgery)
- Numeric rating scale scores for pain(24 hours post-surgery)
- Length of intensive care unit stay(1 week follow up after surgery)
- Opioid related side effects(24 hours post surgery)
研究者
Kamil Darcin
Principal Investigator
Koç University