Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection

April 2, 2026 updated by: aijun xu, Tongji Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS (Visual Analog Scale) pain score
Time Frame: 48 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PCIA-related parameters
Time Frame: 48 hours
Including total analgesic consumption, number of effective presses, and total number of presses
48 hours
Incidence of opioid-related adverse events (ORAEs)
Time Frame: 48 hours
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
Time Frame: 10 days
The length of postoperative hospital stay from the end of surgery to hospital discharge
10 days
The quality of sleep
Time Frame: 10 days
AIS sleep scale was used to assess the quality of sleep
10 days
total dosage of remedial analgesic drugs
Time Frame: 48hours
The total consumption of remedial analgesic drugs within 48 hours post-surgery
48hours
the number of rescue analgesic interventions
Time Frame: 48 hours
the number of rescue analgesic interventions within 48 hours post-surgery
48 hours
overall patient satisfaction
Time Frame: 10 days
overall patient satisfaction post-surgery
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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