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临床试验/NCT05901103
NCT05901103已完成不适用

The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年3月29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
24
试验地点
1
主要终点
Numerical rating scale (NRS) scores

研究概览

简要总结

The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing video-assisted thoracoscopic surgery (VATS).

详细描述

There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All patients had standard general anesthesia. Group S had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated using patient-controlled analgesia (PCA) device.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients older than 18 years of age who underwent video-assisted thoracoscopic surgery (VATS) under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

排除标准

  • •Patients who did not give consent,
  • •patients with coagulopathy,
  • •patients with signs of infection at the block application site,
  • •patients using anticoagulants,
  • •patients with local anesthetic drug allergies,
  • •patients undergoing open surgery,
  • •patients with unstable hemodynamics,
  • •patients who could not cooperate during postoperative pain assessment

研究组 & 干预措施

SPSIPB

Active Comparator

Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. PCA device was also performed to this group with the same protocol which was detailed in control arm.

干预措施: Serratus posterior superior intercostal plane block (SPSIPB) (Other)

Control

No Intervention

Control group patients were not subjected to any block or local infiltration anesthesia (local anesthetic administration around the incision). Their postoperative pain was relieved with tramadol (intravenous analgesic drug) administration by using patient-controlled analgesia (PCA) device. Patient-controlled analgesia was achieved with tramadol hydrochloride at a concentration of 4 mg per 1 ml with the PCA device. The PCA device was configured to administer the patients boluses of 10 mg tramadol hydrochloride with a lockout time of 20 minutes, allowing a maximum of 4 pushes per hour. The total dose was standardized for all patients with a maximum daily dose of 400 mg and a maximum dose of 100 mg tramadol hydrochloride every 6 hours.

结局指标

主要结局

Numerical rating scale (NRS) scores

时间窗: Postoperative 24 hours

Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

次要结局

  • Total tramadol consumption(Postoperative 24 hours)

研究者

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

Oguz Gundogdu

Assisstant Professor

Cumhuriyet University

研究点 (1)

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