Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lobectomy
• Intervention / Treatment: Drug: Sufentanil; Drug: Tegileridine; Procedure: Intercostal Nerve Block

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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aijun Xu, Dr.; Phone Number: 18627784217; Email: ajxu@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Hongbo Zheng, Dr.; Phone Number: 02783663173; Email: 70663307@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: aihua Du, Dr.; Phone Number: 02783663625; Email: 70663307@qq.com
      • Contact: Aijun Xu, Dr.; Phone Number: 18627784217; Email: ajxu@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sufentanil group; 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.	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); Other Names: Sufen; 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.; Other Names: ICNB
Experimental: Tegileridine group; 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; 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); Other Names: Tegi; 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.; Other Names: ICNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCIA-related parameters	Including total analgesic consumption, number of effective presses, and total number of presses	48 hours
Incidence of opioid-related adverse events (ORAEs)	Including Respiratory depression (defined as respiratory rate < 8 breaths/min or SpO₂ < 90%); ② Postoperative nausea and vomiting (PONV); ③ Pruritus; ④ Dizziness; ⑤ Delayed recovery of gastrointestinal function, etc.	48 hours
The length of postoperative hospital stay	The length of postoperative hospital stay from the end of surgery to hospital discharge	10 days
The quality of sleep	AIS sleep scale was used to assess the quality of sleep	10 days
total dosage of remedial analgesic drugs	The total consumption of remedial analgesic drugs within 48 hours post-surgery	48hours
the number of rescue analgesic interventions	the number of rescue analgesic interventions within 48 hours post-surgery	48 hours
overall patient satisfaction	overall patient satisfaction post-surgery	10 days

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Sufentanil
• Other Study ID Numbers: TITL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).
• IPD Sharing Time Frame: Immediately followingpublication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No