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临床试验/NCT06704698
NCT06704698招募中不适用

Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study

Zhejiang Cancer Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年12月3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
招募中
入组人数
132
试验地点
1
主要终点
Overall Benefit of Analgesic Score (OBAS)

研究概览

简要总结

Prevention of postoperative pain is essential for the recovery of esophageal surgery. Epidural analgesia is a traditional and standard perioperative pain management for these patients. Beneficials of epidural analgesia have been widely established. However, there are still several potential disadvantages such as perioperative hypotension, failure of administration, rare but serious neurological complications. Ultrasound-guided regional nerve block has become a widely used technique due to its low degree of trauma and precise target of action. In combined with liposome bupivacaine (LB), a new long-acting local anesthetic, was proven to have a maximum duration of 72 hours, thus improving postoperative analgesia, reducing opioid consumption, and enhancing patient satisfaction. The aim of this study was to evaluate the efficacy of TPVB liposomal bupivacaine (LB) or plane bupivacaine (SB) for Overall Benefit of Analgesic Score (OBAS) after esophageal surgery.

详细描述

After approved by the Ethics Committee of the Cancer Hospital of Zhejiang Province (Approval Number: IRB-2024-1037 (IIT)). This study was registered prior to patient admission. Written informed consent was obtained from all participants. The study is scheduled to run from November 25, 2024, to December 31, 2027. A total of 132 patients with ASA physical status I and III, undergoing thoracoscopic esophagectomy will be included. For patients in the liposomal bupivacaine group, in the left lateral decubitus position, a transversus paravertebral block (TPVB) is performed under ultrasound guidance at the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, injecting 66.5mg (10 ml) liposomal bupivacaine into each space. Postoperative pain control involves patient-controlled intravenous analgesia (PCIA) with 250 μg sufentanil diluted to a total of 250 ml volume with saline. Background dose of 2-3 mL/h, PCA bolus of 2-4 mL depending on height and weight, lockout interval of 15 minutes, and a maximum dose of 10-15 mL.For the standard control group, a T6-T8 epidural block is administered, with 4-6 mL of 0.25% bupivacaine was applied depend on the height and weight. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA), with 141 μg sufentanil and 300 mg bupivacaine hydrochloride diluted to 250 mL. Background dose of 3-6 mL/h, PCA bolus of 3-4 mL, lockout interval of 15 minutes, and a maximum dose of 20 mL.

When a participant's resting VAS score is ≥4 and they request additional pain relief, the first rescue analgesic is a single intravenous dose of acetaminophen or an NSAID (flurbiprofen axetil, 50 mg). For a second rescue, a single intravenous dose of 100 mg tramadol is administered. Additionally, the APS team adjusts the background and bolus doses based on pain relief assessments from the previous 24 hours.

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
Triple (Participant, 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

入选标准

  • American Society of Anesthesiologist physical status I-III;
  • Scheduled elective thoracoscopic esophagectomy(three-incision approach);
  • Approved participation before study.

排除标准

  • Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;
  • Anergic to medications used in this study;
  • Patient have chronic pain;
  • Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;
  • Inability to complete postoperative pain assessments or questionnaires due to communication barriers or mental disorders;

研究组 & 干预措施

Epidural block

Other

For the standard control group, a T6-T8 epidural block is administered. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA).

干预措施: Bupivacaine Hydrochloride (Drug)

Thoracic paravertebral block

Experimental

Ultrasound guided paravertebral block (TPVB) with liposomal bupivacaine is performed in this group. 40ml of liposomal bupivacaine and saline mixture was injected to the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, with 10 ml for each space. Patient-controlled intravenous analgesia (PCIA) is used for postoperative pain management.

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Overall Benefit of Analgesic Score (OBAS)

时间窗: 3 days after surgery.

Record pain, dizziness,vomiting, itching, sweating, feeling cold, and analgesic satisfaction in the first 72 hours. The higher scores mean a worse outcome.

次要结局

  • Area under the curve of mean artery pressure (MAP < 65 mmHg)(From start of anesthesia to the end of surgery, an average of 5 hours.)
  • Visual Analog Scale (VAS)(3 days after surgery.)
  • Total opioid consumption(3 days after surgery.)
  • In-hospital stay(From the end of surgery to discharge of hospital. An average of 10 days.)

研究者

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

xupingbo

Principal Investigator

Zhejiang Cancer Hospital

研究点 (1)

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