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临床试验/NCT06882083
NCT06882083尚未招募不适用

The Effect of Ultrasound-Guided Bilateral Single-Shot Paravertebral Block on Recovery After Coronary Artery Bypass Graft Surgery

Adiyaman University Research Hospital0 个研究点目标入组 120 人开始时间: 2025年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Quality of Recovery -15 (QoR-15) score

研究概览

简要总结

The study aims to evaluate the analgesic efficacy of paravertebral block, mobilization speed, respiratory functions, and complication rates in patients who have undergone cardiac surgery and are monitored in the intensive care unit during the postoperative period.

详细描述

The aim of this study is to evaluate the effects of a single-dose bilateral paravertebral block administered under ultrasound guidance on the recovery process after cardiac surgery. Effective management of postoperative pain in cardiac surgeries is crucial for enhancing patient comfort, reducing complications, and facilitating rapid recovery. Paravertebral block can be utilized as an effective method for pain management following cardiac surgeries. This technique provides extensive analgesic coverage in the thoracic region while reducing opioid consumption and its associated side effects. Additionally, it supports the preservation of respiratory functions, facilitates early mobilization, and may reduce postoperative complications. When performed under ultrasound guidance, the accuracy and efficacy of the block are enhanced, making it a safe analgesic option in cardiac surgeries. Studies have demonstrated that paravertebral block increases patient satisfaction and contributes positively to the recovery process. Therefore, it is a viable approach for postoperative pain management in cardiac surgery.

This study will be conducted with a prospective, randomized, and controlled design. Patients will be assigned to two groups using a sealed-envelope method: the paravertebral block group and the control group. Patients in the paravertebral block group will receive a single-dose bilateral paravertebral block under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic. Patients in the control group will receive a standard analgesia protocol.

All patients will be monitored in the intensive care unit during the postoperative period, and the following parameters will be assessed: pain scores using the visual analog scale (VAS), total opioid consumption, extubation times, intensive care unit length of stay, Quality of Recovery-15 (QoR-15) score, and postoperative complications. Data will be collected during the preoperative assessment and throughout the first 48 hours postoperatively.

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 (Investigator, Outcomes Assessor)

盲法说明

The researchers who performed the blocks did not participate in the outcome assessments, and similarly, the researcher evaluating the outcomes was not involved in the paravertebral block procedures.

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

  • •Patients aged 18 and older scheduled for elective coronary artery bypass graft surgery with median sternotomy

排除标准

  • •Contraindications to neuroaxial block ( coagulopathy, infection at the injection site, allergy to local anesthetics..)
  • •Emergency surgeries
  • •severe back deformities
  • •Chronic pain
  • •refusal to participate
  • •CABG without sternotomy

研究组 & 干预措施

Control group

No Intervention

No intervention planned for control group. Patients in the control group will receive a standard analgesia protocol.

Block group

Experimental

USG guided single-shot paravertebral block planned for block group

干预措施: paravertebral block (Procedure)

结局指标

主要结局

Quality of Recovery -15 (QoR-15) score

时间窗: Postoperative 24th hours

The QoR-15 is a clinically acceptable and feasible patient-centred outcome measure after surgery. The score demonstrated good validity, reliability and responsiveness. The score ranges from 0 to 150. O refers to the worst recovery and 150 refers to best recovery.

次要结局

  • Opioid consumption(Postoperative 24th hours)
  • Visual Analog scale (VAS) score(Postoperative 2nd, 4th, 6th, 12th and 24th hours)
  • Extubation time(Time frame from the end of the surgery to extubation)

研究者

发起方
Adiyaman University Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nezir Yılmaz

Associate Professor

Adiyaman University Research Hospital

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