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临床试验/NCT05357976
NCT05357976已完成不适用

The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年4月25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
75
试验地点
2
主要终点
Pain Scores

研究概览

简要总结

Obesity has become one of the world's leading health problems. It is known that obesity causes many diseases and negatively affects the quality of life. For this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. One of them is postoperative pain. Although there are studies stating that there is no relationship between body mass index (BMI) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. There are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in BMI.

After thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study will compare the effects of BMI on postoperative pain in patients undergoing TPVB for postoperative analgesia and thoracoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Non 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 to 80 years old
  • •ASA physical status I-II-III
  • •BMI 18 to 40 kg/m2
  • •Elective video-assisted thoracoscopic surgery

排除标准

  • •Patient refusing the procedure
  • •Emergency surgery
  • •Chronic opioid or analgesic use
  • •Patients who will operate under emergency conditions
  • •Patients who will not undergo VATS

研究组 & 干预措施

Patients with a BMI of 18-24.9 kg/m2

Active Comparator

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

干预措施: Thoracic Paravertebral Block (Procedure)

Patients with a BMI of 25-29.9 kg/m2

Active Comparator

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

干预措施: Thoracic Paravertebral Block (Procedure)

Patients with a BMI of 30-40 kg/m2

Active Comparator

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

干预措施: Thoracic Paravertebral Block (Procedure)

结局指标

主要结局

Pain Scores

时间窗: 48th-hour after surgery.

Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain Scores

时间窗: 1st hour after surgery.

Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours after surgery.

Pain Scores

时间窗: 2nd-hour after surgery.

Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain Scores

时间窗: 4th-hour after surgery.

Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain Scores

时间窗: 12th-hour after surgery.

Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain Scores

时间窗: 24th-hour after surgery.

Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

次要结局

  • Morphine Consumption(24 hours after surgery)

研究者

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

Nilgün Zengin

Principal İnvestigator

Ankara City Hospital Bilkent

研究点 (2)

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