Analgesic Effectiveness Of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block In Transfemoral Transcatheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP
研究概览
简要总结
Hemodynamic stability is the main goal of the anesthetic method during Transcatheter Aortic Valve Implantation (TAVI). Pain during the procedure may cause patients to move therefore hemodynamic instability. This may lead to undesirable complications for the patient and the physician. At the same time, it may affect the process quality and cause the processing time to be extended. In this prospective-randomised clinical trial, ultrasound-guided transversus abdominis plan block will be performed to reduce pain. We aimed to contribute to the reduction of undesirable outcomes for the patient and physician by providing adequate anesthesia with Transversus Abdominis Plan (TAP) block accompanied by sedation, and to present its impact on the quality of the healthcare service provided by evaluating patient and physician satisfaction.
详细描述
While common aortic valve stenosis was previously treated with surgical aortic valve replacement, with the developments in the field of interventional cardiology, Transcatheter Aortic Valve Implantation (TAVI) has emerged as an alternative to surgery in recent years and has become the first choice in the treatment of inoperable patients with severe aortic stenosis. Especially patients who are elderly, have chronic illnesses, have a high surgical risk, and whose general health condition is not suitable for surgery can be treated with this method.
Mostly the femoral artery is preferred for TAVI access because it has a large lumen (8-9 mm) and has less anatomical variation. After the inguinal ligament, the iliac artery, originating from the abdominal aorta, is called the femoral artery. Since this region is safe, it is preferred in cardiac interventions.
Transversus abdominis plane (TAP) block aims to block the ilioinguinal and iliohypogastric nerves which contribute to the sensory innervation of the femoral region used for endovascular cardiac interventions. No studies have been found on the analgesic efficacy of TAP block in TAVI procedures.
Local anesthesia and sedation as standard procedure will be applied to the control group (SCG) (n: 25). In TAP block group (TAPG) (n:25) standard procedure and unilateral ultrasound (USG)-guided TAP block will be performed. In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target Bispectral index (BIS) between 70 and 80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. If patients experience pain or movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol. All medications will be recorded.
Patients' demographic data, hemodynamic parameters, total anesthetic drug consumption, procedure duration, complications seen during the procedure will be recorded. The pain level felt during procedure from valve positioning to deployment, when placing and withdrawing sheath and during sandbag compression at 4th postoperative hour will be recorded according to the Numeric rating scale-11 (NRS-11) scoring system. 5-point Likert scale will be used for patient and physician satisfaction.
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
Blinding will be maintained for all parties except the block administrator. Specifically, participants, the attending anesthesiologist responsible for intraoperative sedation management, the interventional cardiologist performing the TAVI procedure, the outcome assessor collecting postoperative data, and the statistician will be all blinded to group allocation throughout the study. The block administrator (a regional anesthesia specialist) will be necessarily unblinded due to the technical requirements of ultrasound-guided block application; this individual had no involvement in intraoperative management, outcome assessment, or statistical analysis. In the sham group, 30 mL of isotonic saline (0.9% NaCl) will be injected using identical sonographic conditions and procedural steps to maintain participant blinding."Data analysis will be conducted using coded group labels, and the statistician will remain blinded until completion of the final analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TAVI procedures
- •over 18 years of age
- •elective procedures
- •Signing the volunteer consent form
- •Providing optimal images in ultrasound imaging
排除标准
- •< 18 yers of age
- •emergency procedures
- •morbidly obese patients (BMI>35kg/m2)
- •Advanced decompensated heart failure with New york Heart Association (NYHA) stage 4
- •Those who have skin infection, lesion, hematoma in the area to be blocked
- •Cannot be communicated and cannot be given a position
- •Allergic to the prescribed medications
- •Pregnants
- •Those who refused to sign volunteer consent form
研究组 & 干预措施
Block group
Local anesthesia and sedation will be applied as standard procedure and unilateral USG-guided TAP block will be performed. In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
干预措施: Ultrasound (Device)
Block group
Local anesthesia and sedation will be applied as standard procedure and unilateral USG-guided TAP block will be performed. In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
干预措施: Local anesthesia and sedation (Procedure)
Control group
Local anesthesia and sedation will be administered according to standard procedure. In the control group a simulated TAP block procedure will be performed under ultrasound-guided conditions with injection of the same volume normal saline to maintain blinding; however, no local anesthetic will be administered (C) (n: 25). In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
干预措施: Ultrasound (Device)
Control group
Local anesthesia and sedation will be administered according to standard procedure. In the control group a simulated TAP block procedure will be performed under ultrasound-guided conditions with injection of the same volume normal saline to maintain blinding; however, no local anesthetic will be administered (C) (n: 25). In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
干预措施: Local anesthesia and sedation (Procedure)
结局指标
主要结局
The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP
时间窗: From procedure start to 4 hours post-procedure, assessed at four time points: femoral sheath insertion, intraprocedural valve positioning, femoral sheath removal, and sandbag compression at 4 hours post-procedure.
NRS is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable assessed at four perioperative time points.
次要结局
- Total intraprocedural opioid consumption(from induction to end of procedure)
- Incidence of rescue sedo-analgesia requirement(from induction to end of procedure)
- incidence of sedation-related complications(from induction to 60 minutes post-procedure)
- unexpected patient movement(during procedure)
- patient satisfaction(1 hour after end of procedure)
- physician satisfaction(1 hour after end of procedure)
研究者
Kerem Erkalp, MD, Prof
professor
Istanbul University - Cerrahpasa