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Recruiting NCT07386626

Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

No phase Interventional Lobectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tegileridine, Intercostal Nerve Block, Sufentanil.
Who it may be relevant to
Registry conditions: Lobectomy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study on the Analgesic Effect of Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

Overview

Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. Thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.

Detailed description

Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. ICNB provides rapid and precise incision analgesia in the early postoperative period, effectively blocking the transmission of peripheral nociceptive stimuli to the central nervous system. tegileridine PCIA, on the other hand, enhances the function of the endogenous descending pain suppression system through its central G protein pathway activation, covering the pain period after the effect of ICNB wears off and components such as visceral referred pain. At the same time, it can effectively reduce side effects such as respiratory depression and nausea/vomiting, thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.

Interventions

  • Drug Tegileridine
    Administer 0.015 mg/kg (maximum 1mg) of tegileridine intravenously 40 minutes before the end of surgery, followed by the connection of a tegileridine patient-controlled intravenous analgesia (PCIA)
  • Procedure Intercostal Nerve Block
    Before closing the chest, the thoracic surgeon injected 3mL of 0.4% ropivacaine into the 4th, 5th, 6th and 7th intercostal spaces through thoracoscopy for intercostal nerve block.
  • Drug Sufentanil
    Administer 0.15 μg/kg (maximum 10 μg) of sufentanil intravenously 40 minutes before the end of surgery, followed by the connection of a sufentanil patient-controlled intravenous analgesia (PCIA)

Primary outcome measures

  • VAS (Visual Analog Scale) pain score [Time frame: 48 hours]
Secondary outcome measures (7)
  • total dosage of remedial analgesic drugs [Time frame: 48hours]
  • PCIA-related parameters [Time frame: 48 hours]
  • Incidence of opioid-related adverse events (ORAEs) [Time frame: 48 hours]
  • The length of postoperative hospital stay [Time frame: 10 days]
  • The quality of sleep [Time frame: 10 days]
  • the number of rescue analgesic interventions [Time frame: 48 hours]
  • overall patient satisfaction [Time frame: 10 days]

Eligibility criteria

Inclusion criteria

  • Age range: 18 to 75 years old;
  • Patients undergoing elective thoracoscopic lobectomy or segmentectomy;
  • ASA classification levels I-III;
  • BMI 18 \~ 30 kg/m2。
  • Voluntarily participate and sign an informed consent form.

Exclusion criteria

  • Patients with preoperative alcohol dependence and long-term use of analgesic drugs are receiving analgesic treatment for other acute and chronic pain;
  • Pregnant or lactating women;
  • Allergies or other contraindications to the anesthetics, analgesics, and antiemetic drugs used in the study;
  • Patients with severe sleep apnea syndrome or acute or severe bronchial asthma;
  • Suffering from mental and neurological disorders or cognitive impairment, known or suspected gastrointestinal obstruction, severe liver and kidney dysfunction (Child Pugh score C), chronic obstructive pulmonary disease or severe cardiovascular disease, etc;
  • Researchers consider participants who are not suitable to participate in this study and those who refuse to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji hospital — Wuhan

Publications

  • Zheng H, Pan R, Yuan F, Li J, Xu A. Efficacy of tegileridine combined with intercostal nerve block for postoperative analgesia following thoracoscopic pulmonary resection: a study protocol for a randomised controlled trial. BMJ Open. 2026 May 4;16(5):e118277. doi: 10.1136/bmjopen-2026-118277. PMID 42082224

Identifiers

NCT: NCT07386626 · TITL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗