LobectomyNCT07386626
Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection
A study testing Tegileridine, Intercostal Nerve Block and Sufentanil in people with Lobectomy, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lobectomy
- What is being tested?
- Tegileridine, Intercostal Nerve Block and Sufentanil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 430030
Aijun Xu, Dr., 18627784217, ajxu@tjh.tjmu.edu.cn
aihua Du, Dr., 02783663625, 70663307@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lobectomy
- Being tested
- Tegileridine, Intercostal Nerve Block, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegileridineDrug
Also called Tegi
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)
Intercostal Nerve BlockProcedure or surgery
Also called ICNB
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.
SufentanilDrug
Also called Sufen
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tegileridine; Procedure: Intercostal Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (7)
total dosage of remedial analgesic drugs
The total consumption of remedial analgesic drugs within 48 hours post-surgery
Measured: 48hours
PCIA-related parameters
Including total analgesic consumption, number of effective presses, and total number of presses
Measured: 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.
Measured: 48 hours
The length of postoperative hospital stay
The length of postoperative hospital stay from the end of surgery to hospital discharge
Measured: 10 days
The quality of sleep
AIS sleep scale was used to assess the quality of sleep
Measured: 10 days
the number of rescue analgesic interventions
the number of rescue analgesic interventions within 48 hours post-surgery
Measured: 48 hours
overall patient satisfaction
overall patient satisfaction post-surgery
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start18 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LobectomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386626
- Sponsor's protocol ID
- TITL
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).
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.
PubMed 42082224
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Analgesic Effect of Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection
- ClinicalTrials.gov ID
- NCT07386626
- Acronym / sponsor ID
- TITL
- Conditions
- Lobectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sufentanil group | Active comparator | Procedure: Intercostal Nerve Block, Drug: SufentanilAdminister 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. |
| Tegileridine group | Experimental | Drug: Tegileridine, Procedure: Intercostal Nerve BlockAdminister 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegileridineAlso: TegiAdminister 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) | Drug | Tegileridine group |
| Intercostal Nerve BlockAlso: ICNBBefore 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. | Procedure or surgery | Tegileridine group, sufentanil group |
| SufentanilAlso: SufenAdminister 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) | Drug | sufentanil group |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42082224Zheng 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
aihua Du, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegileridine, Intercostal Nerve Block and Sufentanil in people with Lobectomy, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aijun Xu, Dr. (18627784217, ajxu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analog Scale) pain score (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.