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临床试验/NCT07745881
NCT07745881招募中不适用

Postoperative Analgesic Effects of Ultrasound-guided Retro-superior Costotransverse Ligament Space Block After Video-assisted Thoracoscopic Surgery: a Prospective Randomized Controlled Trial

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
1
主要终点
Postoperative sufentanil dosage

研究概览

简要总结

The aim of this clinical trial is to investigate the effects of postoperative analgesia during retro-SCTLB(retro superior costotransverse ligament space block) and TPVB(thoracic paravertebral block) in patients undergoing thoracoscopic radical resection of lung cancer。By comparing the dosage of opioid drugs after surgery, the impact of retro-SCTLB and TPVB on the postoperative analgesic effect was evaluated.

详细描述

After siged the informed consent form, 130 patients who chosed to undergo thoracoscopic radical resection of lung cancer were randomly divided into two groups: the retro-SCTLB group (Group R, 65 patients) and the TPVB group (Group T, 65 patients).ultrasound-guided retro-SCTLB or TPVB was performed 15min before general anesthesia.

Ultrasound-guided retro-SCTLB method: Using an ultrasound low-frequency convex array probe (3-5 MHZ, Sonosite, USA), the probe was placed parallel to the spine 2-3cm outside the spinous process of the fifth thoracic vertebra, on the surface of the transverse process tip. First, the probe was placed above the rib and costo-transverse process joint and observed from the inside out to clearly show the spinous process, lamina, transverse process and rib. Then, the probe was gently moved towards the caudal side. Until the sound shadows of the ribs and transverse processes disappear and inferior articular processes appear on the medial side, and when high-echo superior ligaments of the costal transverse processes appear behind the paravertebral space and anterolateral of the inferior articular processes, then gently rotate the outer edge of the probe towards the caudal side and a low-echo area can be seen behind the superior ligaments of the costal transverse processes, which is the target area. Then, using a long oblique plane puncture needle, with the in-plane technique, insert the needle from the outer side of the probe. When the needle tip reaches the target area, use the water separation technique to inject 2ml of normal saline to confirm the needle tip position, then inject 20ml of 0.375% ropivacaine; Ultrasound-guided TPVB: Using an ultrasound low-frequency convex array probe (3-5 MHZ, Sonosite, USA), the probe is placed perpendicularly to the spine at the fifth thoracic vertebra on the midline of the trunk. First, the spinous process is identified, and then the ultrasound probe is gradually moved towards the surgical side. Structures such as the transverse process, pleura, and intercostal intima are visible. At this point, the ultrasound probe is moved parallel to the caudal side. The area between the parietal pleura, intercostal endometrium and transverse process is the target area for injection. Then, using a short inclined plane puncture needle, using the in-plane technique, the needle is inserted from the outside of the probe. When the needle tip reaches the target position, 2ml of normal saline is injected using the water separation technique to confirm the needle tip position. Then 20ml of 0.375% ropivacaine is injected; General anesthesia was then performed.General anesthesia was performed as follows: After the patient enters the operating room, routine ECG monitoring was performed, and invasive arterial blood pressure was monitored by radial artery puncture and catheterization. General anesthesia was induced with hydrocortisone 100mg, midazolam 0.5mg/kg, ciprofol 0.4mg/kg, sufentanil 0.4ug/kg, vecuronium 0.1mg/kg, and then a double-lumen bronchial tube was inserted under a videro laryngoscope and mechanically ventilated (tidal volume: 6ml/kg, PEEP: 3-5 cm H2O). Anesthesia was maintained with ciprofol (0.6-1mg.kg.h-1), remifentanil (0.12-0.2ug.kg.min-1) ,micuronium (0.2mg.kg.h-1), with BIS monitoring of anesthesia depth, maintaining the BIS value between 40 and 60. Intraoperative hemodynamics was maintained within 30% of baseline. Dexketoprofen trometamol injection 50mg was given intravenously for analgesia and tropisetron 4mg was given to prevent nausea and vomiting when there were no contraindications during the operation. The fluid infusion is limited to 6ml/kg/h. sufentanil 0.1ug/kg was administered intravenously 10min before the end of the procedure. At the end of the operation, the patient was transferred to PACU with an endotracheal tube. After neuromuscular blocking antagonism, the tracheal tube was extubated.

NRS was used to evaluate the pain scores at rest and during movement at 1, 3, 6, 12 , 24 and 48h after operation by a nurse who was unaware of the grouping. sufentanil 150μg and tropisetron 6mg which were diluted to 250ml were used for patient-controlled intravenous analgesia after operation. The parameters of analgesia pump were set as background dose 0.5 ml/h, bolus 5ml, lockout time 8min. If the NRS score was ≥ 4, 1 mg of oxycodone was administered intravenously for rescue analgesia. The NRS pain score uses a continuous numerical scale from 0 to 10, and the patient selects the most representative number based on their own pain intensity: 0 points (no pain), 1-3 points (mild pain), 4-6 points (moderate pain), 7-10 points (severe pain).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, 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

  • Patients scheduled for thoracoscopic radical lung cancer surgery under general anesthesia;
  • aged 18-80 years;
  • BMI 18-30 kg/m²;
  • ASA classification I-III;

排除标准

  • Allergy to the study drug or local anesthetic;
  • History of opioid abuse;
  • Pre-existing skin infection at the puncture site of ITPN or TPVB;
  • Peripheral infectious neuropathy;
  • Dysfunction of blood coagulation;

研究组 & 干预措施

retro-SCTLB group

Experimental

A total of 20 ml of the 0.375% ropivacaine is injected in the retro-superior costotransverse ligament space in the retro-SCTLB group。

干预措施: Ultrasound-guided retro-SCTLB (Procedure)

TPVB group

Experimental

A total of 20 ml of the 0.375% ropivacaine is injected in the paravertebral space in the TPVB group .

干预措施: Ultrasound-guided TPVB (Procedure)

结局指标

主要结局

Postoperative sufentanil dosage

时间窗: 24 hour postoperatively

Cumulative sufentanil dosage 24 hour postoperatively

次要结局

  • NRS(Numeric Rating Scales) score(Postoperative 1, 3, 6, 12, 24, 48 hour)
  • Opioid dosage(From the start of the anesthesia until the end of the surgery)
  • Adverse reaction(24, 48 hour postoperatively)
  • Time of first ambulation after surgery(Up to 48 hours postoperative)
  • QoR-15 score(Day 1 and 2 postoperatively)
  • length of patient stays(Up to 15 days postoperative)

研究者

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

Tao Shan

deputy chief physician

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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