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临床试验/NCT06971432
NCT06971432已完成不适用

Comparison of the Effectiveness of Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter on Postoperative Pain After Minimally Invasive Cardiac Surgery

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年4月1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
46
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

A total of 46 patients scheduled to undergo elective coronary artery bypass surgery via a minimally invasive technique will be included in the study. In the preoperative period, patients will be randomly assigned into two groups using the sealed envelope method (SAPB / PECS II).

Upon arrival in the operating room, patients will undergo ECG and SpO₂ monitoring, followed by intra-arterial cannulation for continuous blood pressure monitoring. Anesthesia induction will be performed with 1 mg/kg lidocaine, 2-3 mg/kg propofol, 3 mcg/kg fentanyl, and 0.6 mg/kg rocuronium. Following endotracheal intubation, jugular vein cannulation will be performed.

Group 1:

Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.

Group 2:

Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.

The following variables will be recorded: patient age, height, body weight, BMI, gender, type of analgesia administered, diagnosis, surgical procedure performed, any complications during or after the procedure, postoperative visual analogue scale (VAS) pain scores, additional postoperative analgesic use, patient satisfaction, postoperative nausea and vomiting, ICU length of stay, and total hospital length of stay.

All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

详细描述

SAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior.

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)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Women and men aged 18-75,
  • •ASA I-II-III risk group,
  • •Body mass index between 18-35,
  • •who will undergo coronary artery bypass surgery with minimally invasive cardiac surgery method

排除标准

  • •Those under 18 and over 75
  • •Those with advanced comorbidities
  • •Those with ASA score IV
  • •Those with a history of bleeding diathesis and those using drugs that cause bleeding disorders
  • •Patients with an infection in the area where the block will be performed
  • •Patients who are allergic to the local anesthetic agent to be used
  • •Patients with a body mass index (BMI) under 18 and over 35 will be excluded from the study.
  • •Withdrawal criteria:
  • •Patients who want to leave the study group
  • •Patients who develop surgical complications will be removed from the study.

研究组 & 干预措施

Group SAPB

Experimental

SAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior.

Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.

All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

干预措施: Group SAPB (Procedure)

Group SAPB + LIA

Experimental

SAPB is applied similarly to the other group. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.

All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

干预措施: Group SAPB + LIA (Procedure)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 48 hours

The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their pain will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the intensity of their pain, and the response will be recorded. A score of 0 indicates no pain, and 10 indicates unbearable, severe pain. Measurements will be taken four times: T4: 6th hour postoperatively T5: 12th hour postoperatively T6: 24th hour postoperatively T7: 48th hour postoperatively

次要结局

  • Heart Rate(48 hours)
  • Mean Arterial Blood Pressure(48 hours)
  • Oxygen Saturation(48 hours)
  • Vomiting(48 hours)
  • Itching(48 hours)
  • Additional Analgesics(48 hours)
  • Nausea(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Kurtbeyoğlu

doctor

Ankara City Hospital Bilkent

研究点 (1)

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