ClinicalTrials.gg
RecruitingNCT07412223Updated Aug 17, 2026

Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery

A Phase 4 interventional study of Tegileridine and Morphine in Pain, Postoperative and Postoperative Ileus, sponsored by Xiangya Hospital of Central South University. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 248 studies in Pain, Postoperative with a site in China — 78 open to participants now, 80 under way, 3 of them phase 3. Pain, Postoperative · China.

Planned enrollment
81st of 205
152 · median 132
Started
2026
with 34 others
Phase 4
67 of 248
18 open now
Primary completion
2026-12
later than 50 of 79 live
Registered
218th of 248
by date

Among the 248 studies in Pain, Postoperative with a site in China, this one is the 81st largest by planned enrollment of the 205 interventional ones that give a count, is one of 35 that started in 2026, is one of 67 in phase 4, reaches primary completion later than 50 of the 79 other live ones, and was the 218th registered.

Pain, Postoperative

5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

78 of the 248 studies in Pain, Postoperative with a site in China are open now. Recruiting first, the newest first:

72 more — sign in →

All 78 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 248 studies in Pain, Postoperative with a site in China, or all of them as a file.
02

Study summary

Title: Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial

The goal of this clinical trial is to evaluate the effectiveness and safety of tegileridine, a biased μ-opioid receptor agonist, for patient-controlled intravenous analgesia (PCIA) after abdominal surgery.

The main question it aims to answer is:

Is tegileridine superior to morphine in promoting the recovery of gastrointestinal function within 72 hours after abdominal surgery?

Researchers will compare the experimental group (receiving Fumarate Tegileridine Injection) to the active control group (receiving Morphine Hydrochloride Injection). Both groups will also receive dexmedetomidine in their PCIA pumps. This comparison will determine if tegileridine is more effective for bowel recovery and has a better safety profile.

Participants who are scheduled for elective abdominal surgery under general anesthesia will:

  1. Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery.
  2. Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain.
  3. Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement).
  4. Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization.
  5. Be followed up 30 days after surgery.
03

Conditions studied

  • Pain, Postoperative
  • Postoperative Ileus

Browse trials for

Keywords

  • Tegileridine
  • Postoperative Ileus
  • Postoperative Pain
  • GI-3 composite endpoint
  • Abdominal Surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Scheduled to undergo elective abdominal surgery under general anesthesia.
  2. Age ≥ 18 years.
  3. (BMI) between 18 and 30 kg/m².
  4. (ASA) physical status classification of I to III.
  5. Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.
  6. Understands the trial objectives and voluntarily participates, providing written .

Exclusion criteria

Exclusion Criteria:

  1. Undergoing gastrointestinal tract surgery.
  2. Has advanced cancer with ascites or extensive , or is receiving systemic chemotherapy/radiotherapy, or requires postoperative hyperthermic intraperitoneal chemotherapy (HIPEC).
  3. Diagnosed or suspected gastrointestinal obstruction or emptying disorder.
  4. History of severe cardiovascular or cerebrovascular disease (e.g., severe sinus bradycardia, myocardial infarction, unstable angina, grade II or higher atrioventricular block, history of arrhythmia, class II or higher heart failure, ischemic stroke) or abnormal interval at screening ( >450 ms for males, >470 ms for females).
  5. Comorbid psychiatric or neurological disorders (e.g., schizophrenia, depression, epilepsy) or cognitive dysfunction.
  6. Known allergy to opioid drugs or any component of the trial medications.
  7. Current acute or chronic pain conditions, or presence of hyperalgesia or other sensory disorders.
  8. Long-term opioid therapy (defined as receiving >15 mg morphine milligram equivalents per day for more than 3 days per week, over a period exceeding 1 month within the 12 months prior to surgery).
  9. Pregnant or breastfeeding women, or those with a positive pregnancy test at screening or on the day of surgery; or participants (including males) planning for pregnancy.
  10. Significant hepatic or renal dysfunction (e.g., /AST > 3 times the , or requiring renal replacement therapy).
  11. Planned admission to the Intensive Care Unit (ICU) for postoperative management.
  12. Participation in another interventional clinical trial within the 3 months prior to randomization.
  13. Any other condition deemed by the investigator as unsuitable for participation in this trial.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Tegileridine PCIA Group

    Drug: Tegileridine

  • Active comparator
    Morphine PCIA Group

    Drug: Morphine

Interventions

  • Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the investigational drug, Tegileridine Fumarate Injection, at a concentration of 0.05 mg/mL, and the adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump is programmed with no continuous background infusion (0 mL/h). A loading dose of 20 mL is administered at the start. Thereafter, participants can self-administer a 4 mL bolus on-demand for pain relief, with a maximum allowable dose of 12 mL per hour and a lockout interval of 10 minutes between boluses. This intervention is planned for a duration of 72 hours following abdominal surgery.

  • Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the active comparator drug, Morphine Hydrochloride Injection, at a concentration of 0.25 mg/mL, and the same adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump parameters are identical to Arm 1: no continuous background infusion (0 mL/h), a 20 mL loading dose, a 4 mL on-demand bolus dose, a maximum limit of 12 mL per hour, and a 10-minute lockout interval. This intervention is also planned for a duration of 72 hours post-surgery. The sole distinction between the two arms is the core analgesic agent (Tegileridine vs. Morphine) within the otherwise identical PCIA regimen.

06

What researchers measure

Primary outcomes

  1. Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery.

    Gastrointestinal function recovery is defined by the GI-3 composite endpoint: the ability to tolerate solid food (time to first tolerance of solid food) AND having either flatus (time to first flatus) or bowel movement (time to first bowel movement). The proportion is calculated as the number of participants who meet this composite endpoint within 72 hours after surgery divided by the total number of participants analyzed.

    Time frame: Within 72 hours after abdominal surgery.

Secondary outcomes

  1. Time to GI-3 recovery.

    The time (in hours) from the end of surgery until the participant first meets the GI-3 composite endpoint (tolerating solid food AND having flatus or bowel movement).

    Time frame: From end of surgery up to 7 days postoperatively.

  2. Time to first tolerance of solid food.

    The time (in hours) from the end of surgery until the participant first tolerates solid food.

    Time frame: From end of surgery up to 7 days postoperatively.

  3. Time to first flatus.

    The time (in hours) from the end of surgery until the participant has the first passage of flatus.

    Time frame: From end of surgery up to 7 days postoperatively.

  4. Overall Benefit of Analgesia Score (OBAS).

    The OBAS is a composite score (range 0-28) assessing pain at rest, opioid-related side effects (vomiting, pruritus, sweating, shivering, dizziness), and satisfaction with analgesia. A lower score indicates a higher overall benefit. It will be assessed at 24h, 48h, and 72h postoperatively.

    Time frame: At 24, 48, and 72 hours postoperatively.

  5. Quality of Recovery-15 (QoR-15) Score.

    The QoR-15 is a 15-item patient-reported questionnaire assessing the quality of recovery after anesthesia and surgery. Total scores range from 0 (extremely poor quality of recovery) to 150 (extremely high quality of recovery).

    Time frame: At 24 hours postoperatively.

  6. Time to meet criteria for hospital discharge.

    The time (in hours) from the end of surgery until the participant meets the standard discharge criteria of the participating center, as determined by the attending physician.

    Time frame: From end of surgery through study completion, an average of 7 days.

  7. Richards-Campbell Sleep Questionnaire (RCSQ) Score.

    The RCSQ is a 5-item visual analog scale assessing nighttime sleep quality, including depth of sleep, sleep latency, awakenings, ease of returning to sleep, and overall sleep quality. Each item scores 0-100, and the mean of the five items is the total score, with higher scores indicating better sleep quality.

    Time frame: Daily from postoperative day 1 to postoperative day 3 (assessing the previous night's sleep).

  8. Resting pain assessed by Numerical Rating Scale (NRS).

    Pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable".

    Time frame: At 24, 48, 72 hours postoperatively

  9. Time to first bowel movement post-operatively.

    The time (in hours) from the end of the surgical procedure to the patient's first occurrence of a bowel movement.

    Time frame: From end of surgery up to 7 days postoperatively.

07

Study locations

3 of 3 sites recruiting
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
  • Hunan Provincial Maternal and Child Health Care Hospital
    Changsha, Hunan 410000, China
    Recruiting
  • Xiangya hospital of Central South Univesity
    Changsha, Hunan 410000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 9 months is below that.

Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2026
First posted
Feb 17, 2026
StartActual
Feb 24, 2026
Primary completionEst.
Dec 1, 2026
CompletionEst.
Feb 24, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07412223
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Hunan Provincial Maternal and Child Health Care Hospital
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Feb 24, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Feb 24, 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Longyan Li, M.D., Ph.D.
Contact
lilongyan206@csu.edu.cn
+86-15273139192
Lirui Xian, M.B.
Contact
xianlirui123@163.com
+86-19198053454
Zongbin S. Song, M.D., Ph.D.
study director · Xiangya Hospital of Central South University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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