Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During Subcutaneous Implantable Cardioverter-defibrillator (SICD) Implantation Procedure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- EOA
研究概览
简要总结
Our study consists of a combination of regional blockade ('local' anesthesia) of the anterior and lateral chest wall in the form of a thin needle prick and the supply of local anesthetic drugs to the area of the relevant chest wall structures to exclude all stimuli, including pain from the operative site. A short-acting analgesic and sedative drug will be administered intravenously throughout the procedure - in a dose that allows the required contact between the patient and the anesthetist. If necessary, the dose of the drug may be increased to maintain pain comfort throughout the procedure.
The anesthetic team will be with the patient throughout the procedure to ensure comfort and safety.
详细描述
The current study is a continuation of the 2021-2023 project, during which 16 patients were anesthetized using a combination of previously known regional (PSP +SSAP) blocks in the thoracic area for S-ICD implantation. PSP (pectoserratus plane) block, previously known in scientific nomenclature as (PECS II /DPP/ PNB II) is a block placed under the pectoralis minor muscle between the pectoralis anterior muscle or also under it in the area of the III/IV rib lateral to the midclavicular line. SSAP (superficial serratus anterior plane) block is formerly known as SABP block, which is a block placed at the height of the fifth intercostal in the medial/posterior axillary line between the anterior pterygoid muscle and the dorsal widest muscle.
In some cases, this allowed the procedure to be carried out due to patient burdens, relative contraindications and high risk of complications during general anesthesia. After studies related to the volume of local anesthetics administered as well as the concentration of their mixture, the optimal concentration of the substance used for regional blockade was chosen. This is a mixture of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60mL of administered solution.
Superficial parastenal intercostal plane block (SPIP) formerly known as TTP/ PIP/ PIFP/ SIP/ PSP which is an alternative combination in combination with SSAP is a block in which we deposit a local anesthetic in the parasternal line at the level of the 4th and 5th intercostal spaces between the internal intercostal muscle and the transverse thoracic muscle.
The purpose of the study is to determine whether SPIP+SSAP blockade is the optimal form of anesthesia for S-ICD implantation.
The patient, after qualifying by the cardiologist for S-ICD implantation, will undergo a standard anesthesiological qualification process with evaluation of basic demographic parameters, examination of body mass composition by bioimpedance, comorbidities, medications taken, determination of surgical risk according to the ASA scale ( American Society of Anesthesiology) in addition, the patient will be checked for any contraindications to the use of regional blockade as a method of anesthesia. After qualification, the patient will be asked to read the consent to participate in the study and sign the informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
Anesthesiologists administering anesthesia prior to surgery receive an envelope with a randomly indicated method of anesthesia based on simple randomization determines the type of regional blockade used during the procedure). The subject will not know which study group he or she has been classified into. The operator performing the procedure will not be informed of the type of anesthesia performed -[randomization by double-blinding]. The operator performing the procedure will not be informed about the type of block performed in order to objectivize the extent and quality of the subject's anesthesia, which he will evaluate after the procedure according to a scale of subjective operator comfort created (EOA scale).
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-90 years requiring S-ICD implantation for cardiac indications,
- •high risk of anesthesia (ASA II or higher), patients giving informed consent to participate in the study.
排除标准
- •absolute contraindications to regional anesthesia such as generalized coagulation disorders, inflammation at the site of anesthesia, allergy to the drugs used for regional anesthesia
- •lack of consent of the patient for the conducted procedure,
- •inability to cooperate with the patient - such as severe mental retardation, unregulated mental illness with motor agitation, advanced neurodegenerative diseases such as Parkinson's disease/Alzheimer's,
- •inability to give informed consent to participate in the study.
研究组 & 干预措施
Group I (PSP+SSAP)
Group I will include patients undergoing PSP(Pectoserratus plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.
干预措施: Regional anaesthetic combined fascial plane block (Procedure)
Group I (PSP+SSAP)
Group I will include patients undergoing PSP(Pectoserratus plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.
干预措施: Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution (Drug)
Group I (SPIP+SSAP)
Group II will include patients undergoing SPIP(Superficial parastenal intercostal plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.
干预措施: Regional anaesthetic combined fascial plane block (Procedure)
Group I (SPIP+SSAP)
Group II will include patients undergoing SPIP(Superficial parastenal intercostal plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.
干预措施: Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution (Drug)
结局指标
主要结局
EOA
时间窗: Checked immediately after the procedure (last suture)
Effectiveness of Anaesthesia) -scale (-3 do +3) points
QoR - 15
时间窗: Administered to the patient before surgery and 24 hours after surgery
post-operative quality of life and improvement scale 0-150 points
RASS
时间窗: Checked at regular 15 minute intervals during the procedure
Richmond arousal/sedation scale) (-5 \<-\>+5) points
GCS
时间窗: Checked at regular 15 minute intervals during the procedure
Glasgow level of consciousness score scales 3-15 points
NRS
时间窗: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure
numerical pain scale 0-10 points
VAS
时间窗: Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure
visual analogue scale 0-10 points
次要结局
- HR(Monitored every 5 minutes during the procedure)
- NIBP(Monitored every 5 minutes during the procedure)
- SpO2(Monitored every 5 minutes during the procedure)
研究者
Marek Szamborski
Senior Assistant, MD
4th Military Clinical Hospital with Polyclinic, Poland