Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

NCT07386626 | Recruiting

• 1 other identifier: TITL
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lobectomy

Outcome Measures

Primary Outcomes (1)

• VAS (Visual Analog Scale) pain score

  VAS pain score 0-10, the higher scores mean a worse outcome; Analgesic effect assessed during activity in the post-anesthesia care unit (PACU) and at 1, 6, 12, 24, 36, and 48 hours post-surgery

  48 hours

Secondary Outcomes (7)

• total dosage of remedial analgesic drugs

  48hours

• PCIA-related parameters

  48 hours

• Incidence of opioid-related adverse events (ORAEs)

  48 hours

• The length of postoperative hospital stay

  10 days

• The quality of sleep

  10 days

Study Arms (2)

sufentanil group

ACTIVE COMPARATOR

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). Analgesic pump formula: Sufentanil 150 μg + 0.9% normal saline, total volume 150 mL (containing sufentanil 1 μg/mL). PCIA settings: Single loading dose 1 mL (containing sufentanil 1 μg), lockout interval 10 min, background infusion 1 mL/h.

Procedure: Intercostal Nerve Block; Drug: Sufentanil

Tegileridine group

EXPERIMENTAL

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). Analgesic pump formula: Tigrilidine 15,000 μg + 0.9% normal saline, total volume 150 mL (containing Tigrilidine 100 μg/mL). PCIA settings: Single loading dose 1 mL (containing Tigrilidine 100 μg), lockout interval 10 min, background infusion 1 mL/h.

Drug: Tegileridine; Procedure: Intercostal Nerve Block

Interventions

Tegileridine DRUG

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)

Also known as: Tegi

Tegileridine group

Sufentanil DRUG

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)

Also known as: Sufen

sufentanil group

Intercostal Nerve Block PROCEDURE

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.

Also known as: ICNB

Tegileridine group; sufentanil group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• aihua Du, Dr.

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Aijun Xu, Dr.

CONTACT

18627784217; ajxu@tjh.tjmu.edu.cn

Hongbo Zheng, Dr.

CONTACT

02783663173; 70663307@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately followingpublication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

CN (1)