Pain, PostoperativePhase 4NCT07412223
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
A Phase 4 study testing Tegileridine and Morphine in people with Pain, Postoperative and Postoperative Ileus, run by Xiangya Hospital of Central South University at 3 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Postoperative Ileus
- What is being tested?
- Tegileridine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesChina
- Study dates
- 24 Feb 2026to 24 Feb 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo elective abdominal surgery under general anesthesia.
- Age ≥ 18 years.
- Body Mass Index (BMI) between 18 and 30 kg/m².
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
- Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.
- Understands the trial objectives and voluntarily participates, providing written informed consent.
Who cannot join
- Undergoing gastrointestinal tract surgery.
- Has advanced cancer with ascites or extensive metastasis, or is receiving systemic chemotherapy/radiotherapy, or requires postoperative hyperthermic intraperitoneal chemotherapy (HIPEC).
- Diagnosed or suspected gastrointestinal obstruction or emptying disorder.
- 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, NYHA class II or higher heart failure, ischemic stroke) or abnormal QTcF interval at screening ( >450 ms for males, >470 ms for females).
- Comorbid psychiatric or neurological disorders (e.g., schizophrenia, depression, epilepsy) or cognitive dysfunction.
- Known allergy to opioid drugs or any component of the trial medications.
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- Current acute or chronic pain conditions, or presence of hyperalgesia or other sensory disorders.
- 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).
- 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.
- Significant hepatic or renal dysfunction (e.g., ALT/AST > 3 times the upper limit of normal, or requiring renal replacement therapy).
- Planned admission to the Intensive Care Unit (ICU) for postoperative management.
- Participation in another interventional clinical trial within the 3 months prior to randomization.
- Any other condition deemed by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, 410000
- Recruiting
Xiangya hospital of Central South Univesity
Changsha, Hunan, 410000
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial
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.
Read more
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:
- Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery.
- Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain.
- Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement).
- Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization.
- Be followed up 30 days after surgery.
- Conditions
- Pain, Postoperative, Postoperative Ileus
- Being tested
- Tegileridine, Morphine
- Keywords
- Tegileridine, Postoperative Ileus, Postoperative Pain, GI-3 composite endpoint, Abdominal Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegileridineDrug
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.
MorphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tegileridine PCIA Group | Experimental | Not described Receives: Drug: Tegileridine |
| Morphine PCIA Group | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after abdominal surgery.
Secondary outcomes (9)
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).
Measured: From end of surgery up to 7 days postoperatively.
Time to first tolerance of solid food.
The time (in hours) from the end of surgery until the participant first tolerates solid food.
Measured: From end of surgery up to 7 days postoperatively.
Time to first flatus.
The time (in hours) from the end of surgery until the participant has the first passage of flatus.
Measured: From end of surgery up to 7 days postoperatively.
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.
Measured: At 24, 48, and 72 hours postoperatively.
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).
Measured: At 24 hours postoperatively.
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.
Measured: From end of surgery through study completion, an average of 7 days.
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.
Measured: Daily from postoperative day 1 to postoperative day 3 (assessing the previous night's sleep).
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".
Measured: At 24, 48, 72 hours postoperatively
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.
Measured: From end of surgery up to 7 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Hunan Provincial Maternal and Child Health Care Hospital
- Responsible party
- Sponsor
- Investigators
- Zongbin S. Song, M.D., Ph.D., Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412223
- Sponsor's protocol ID
- 202601008
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07412223
- Acronym / sponsor ID
- 202601008
- Conditions
- Pain, Postoperative, Postoperative Ileus
- Keywords
- Tegileridine, Postoperative Ileus, Postoperative Pain, GI-3 composite endpoint, Abdominal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Hunan Provincial Maternal and Child Health Care Hospital
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 17 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.
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:
- Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery.
- Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain.
- Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement).
- Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization.
- Be followed up 30 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegileridine PCIA Group | Experimental | Drug: Tegileridine |
| Morphine PCIA Group | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo elective abdominal surgery under general anesthesia.
- Age ≥ 18 years.
- Body Mass Index (BMI) between 18 and 30 kg/m².
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
- Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.
Key exclusion criteria (13 listed)
- Undergoing gastrointestinal tract surgery.
- Has advanced cancer with ascites or extensive metastasis, or is receiving systemic chemotherapy/radiotherapy, or requires postoperative hyperthermic intraperitoneal chemotherapy (HIPEC).
- Diagnosed or suspected gastrointestinal obstruction or emptying disorder.
- 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, NYHA class II or higher heart failure, ischemic stroke) or abnormal QTcF interval at screening ( >450 ms for males, >470 ms for females).
- Comorbid psychiatric or neurological disorders (e.g., schizophrenia, depression, epilepsy) or cognitive dysfunction.
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 |
|---|---|---|
| TegileridineParticipants 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. | Drug | Tegileridine PCIA Group |
| MorphineParticipants 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. | Drug | Morphine PCIA Group |
Primary outcome
Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery.
Time frame: Within 72 hours after abdominal 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.
9 secondary outcomes
Time to GI-3 recovery.
Time frame: From end of surgery up to 7 days postoperatively.
Time to first tolerance of solid food.
Time frame: From end of surgery up to 7 days postoperatively.
Time to first flatus.
Time frame: From end of surgery up to 7 days postoperatively.
Overall Benefit of Analgesia Score (OBAS).
Time frame: At 24, 48, and 72 hours postoperatively.
Quality of Recovery-15 (QoR-15) Score.
Time frame: At 24 hours postoperatively.
Time to meet criteria for hospital discharge.
Time frame: From end of surgery through study completion, an average of 7 days.
Richards-Campbell Sleep Questionnaire (RCSQ) Score.
Time frame: Daily from postoperative day 1 to postoperative day 3 (assessing the previous night's sleep).
Resting pain assessed by Numerical Rating Scale (NRS).
Time frame: At 24, 48, 72 hours postoperatively
Time to first bowel movement post-operatively.
Time frame: From end of surgery up to 7 days postoperatively.
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 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zongbin S. Song, M.D., Ph.D. study director
Xiangya Hospital of Central South University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegileridine and Morphine in people with Pain, Postoperative and Postoperative Ileus, run by Xiangya Hospital of Central South University at 3 sites 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 6 inclusion and 13 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Longyan Li, M.D., Ph.D. (+86-15273139192, lilongyan206@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery. (time frame: Within 72 hours after abdominal surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.