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临床试验/NCT05723341
NCT05723341已完成不适用

Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy

Istanbul University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2023年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Postoperative Intravenous Total Morphine Consumption

研究概览

简要总结

Most of the patients undergoing laparoscopic partial/radical nephrectomy can experience moderate or severe postoperative pain, and inadequate control of this pain can cause negative consequences such as development of chronic pain, pulmonary and cardiac events, and side effects of long term opioid usage. Due to these adverse outcomes, ultrasonography-guided plane blocks can be beneficial for these patients to decrease opioid consumption. In this study, the investigators aim to compare ultrasonography-guided plane blocks: Paravertebral block and subcostal transversus abdominis plane block and traditional method: patient controlled analgesia with opioids. The investigators hypothesized that analgesic efficacy in both paravertebral and subcostal TAP blocks will have similar outcomes but better than traditional method.

详细描述

More than half of patients undergoing laparoscopic partial/radical nephrectomy develop moderate or severe postoperative pain. Inadequate control of postoperative pain may delay early mobilization and rehabilitation, increase pulmonary and thromboembolic events, prolong hospital stay, and decrease patient satisfaction. Inadequate postoperative pain control may lead to the development of chronic pain, resulting in long-term opioid use. In the traditional analgesia model provided with opioids, patients may develop side effects such as nausea, vomiting, hypotension, loss of consciousness, and respiratory depression. For this reason, it would be more rational to provide analgesia with regional methods, which are decided according to the suitability of the patient and the surgical procedure, rather than the use of intravenous drugs. Ultrasonography-guided plane blocks, one of the main elements of multimodal analgesia, are used more frequently with the introduction of ultrasonography into daily practice. These blocks are frequently preferred in daily practice as they reduce opioid consumption by providing effective postoperative analgesia with low complication rates and ease of application.

In the ultrasonography-guided paravertebral block, local anesthetic is injected into the triangle constituted by superior costotransvers ligament, parietal pleura and vertebral body where the spinal nerves emerge from the intervertebral foramen. Ipsilateral somatic and sympathetic nerve blockade is observed. It is a body block that can be used to provide both analgesia and anesthesia. Paravertebral block provides successful postoperative analgesia, reduces the decline in postoperative respiratory function, accelerates the recovery of respiratory mechanics, and reduces postoperative vomiting, allowing earlier initiation of oral intake.

Ultrasonography-guided subcostal transversus abdominis plane block is a relatively safe and simple body block in which local anesthetic is injected into the fascial plane located between posterior rectus sheath and transversus abdominis muscle. The transversus abdominis plane is the fascial plane superficial to the transversus abdominis muscle, the innermost muscular layer of the anterolateral abdominal wall. The subcostal transversus abdominis plane block ideally anesthetizes the intercostal nerves T6-T9 between the rectus abdominis sheath and the transversus abdominis muscle. It is a truncal block that has drawn attention recently, both because it is easier to apply and because it is a more peripheral block.

In this study the investigators aim to compare the effects of two truncal blocks on postoperative pain, morphine consumption, chronic pain and complications.

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
Single (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

入选标准

  • Age of 18-75
  • Patients who are ASA (American Society of Anesthesiology): I-II
  • Patients who will have laparoscopic partial/radical nephrectomy
  • Patients who volunteer to participate in the study

排除标准

  • Patients with any kind of coagulopathy
  • Patients with severe cardiac, pulmonary, renal or liver disease
  • Patients who have difficulty comprehending the IV PCA device
  • Patients with local anesthetic allergy
  • Patients with chronic opioid use

研究组 & 干预措施

Paravertebral Block Group

Active Comparator

In this group, preoperative ultrasound-guided paravertebral block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 in the paravertebral space.

干预措施: Bupivacain (Drug)

Paravertebral Block Group

Active Comparator

In this group, preoperative ultrasound-guided paravertebral block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 in the paravertebral space.

干预措施: Morphine (Drug)

Subcostal Transversus Abdominis Plane Block Group

Active Comparator

In this group, preoperative ultrasound-guided subcostal transversus abdominis plane block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 into the fascial plane between erector spine muscle and transverse process

干预措施: Bupivacain (Drug)

Subcostal Transversus Abdominis Plane Block Group

Active Comparator

In this group, preoperative ultrasound-guided subcostal transversus abdominis plane block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 into the fascial plane between erector spine muscle and transverse process

干预措施: Morphine (Drug)

Intravenous Patient Controlled Analgesia

Active Comparator

In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.

干预措施: Morphine (Drug)

结局指标

主要结局

Postoperative Intravenous Total Morphine Consumption

时间窗: Up to 24 hours

The total dosage of intravenous morphine consumption in 24 hours.

次要结局

  • Rescue analgesia administration amounts(Up to 24 hours)
  • Incidence of complications due to the regional blocks(Up to first week)
  • Chronic postoperative pain(Up to 90th day)
  • Lenght of Hospital Stay(Up to first week)
  • Postoperative Visual Analog Score (VAS)(Up to 24 hours)

研究者

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

Meltem Savran Karadeniz

Associate professor

Istanbul University

研究点 (1)

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