Postoperative PainPhase 4TASPERNCT07637968
Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery
A Phase 4 study testing Tegileridine, Sufentanil and Palonosetron in people with Postoperative Pain, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Tegileridine, Sufentanil and Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Elective major abdominal surgery as defined above.
- Body mass index (BMI) 18-30 kg/m².
- American Society of Anesthesiologists (ASA) physical status I to III.
- Written informed consent.
Who cannot join
- Known hypersensitivity to opioids or any component of the study medications.
- Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
- Pregnancy or breastfeeding.
- Severe hepatic impairment (Child-Pugh class C).
- Severe heart failure (NYHA class III-IV) or unstable arrhythmia.
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- Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness).
- History of chronic pain or long-term use of analgesics/analgesic products.
- Current use of sedative-hypnotic medications.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
- Conditions
- Postoperative Pain
- Being tested
- Tegileridine, Sufentanil, Palonosetron
- 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
Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
SufentanilDrug
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
PalonosetronDrug
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Tegileridine Group | Experimental | Participants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. Receives: Drug: Tegileridine; Drug: Palonosetron |
| Sufentanil Group | Active comparator | Participants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. Receives: Drug: Sufentanil; Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU.
Measured: From 0 to 24 hours after admission to the PACU
Secondary outcomes (8)
Resting and Movement Pain Intensity
Resting and movement pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be recorded at 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU.
Measured: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
PCIA Demand and Effective Press Counts
Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.
Measured: Within 48 hours after admission to the PACU.
Use of Rescue Analgesia
The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.
Measured: Within 72 hours after admission to the PACU
Incidence and Severity of PONV
The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed using a standardized nausea and vomiting assessment scale within 72 hours after admission to the PACU.
Measured: Within 72 hours after admission to the PACU
Time to First Flatus
Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.
Measured: From admission to the PACU until first passage of flatus, assessed up to 1 week.
Time to First Bowel Movement
Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.
Measured: From admission to the PACU until first bowel movement, assessed up to 1 week.
Time to Resumption of Oral Intake
Time to resumption of oral intake will be defined as the time from admission to the PACU to the first postoperative intake of liquids, semi-liquid food, or regular diet.
Measured: From admission to the PACU until resumption of oral intake, assessed up to 1 week.
Length of Postoperative Hospital Stay
Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.
Measured: From admission to the PACU until hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group for postoperative patient-controlled intravenous analgesia.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Jiang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637968
- Sponsor's protocol ID
- IIT-CRU-FAMB-2026HS100
- Acronym
- TASPER
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial
- ClinicalTrials.gov ID
- NCT07637968
- Acronym / sponsor ID
- TASPER / IIT-CRU-FAMB-2026HS100
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Jun 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.
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group for postoperative patient-controlled intravenous analgesia.
| Arm | Type | Receives |
|---|---|---|
| Tegileridine Group | Experimental | Drug: Tegileridine, Drug: PalonosetronParticipants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. |
| Sufentanil Group | Active comparator | Drug: Sufentanil, Drug: PalonosetronParticipants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. |
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 18-75 years.
- Elective major abdominal surgery as defined above.
- Body mass index (BMI) 18-30 kg/m².
- American Society of Anesthesiologists (ASA) physical status I to III.
- Written informed consent.
Key exclusion criteria (9 listed)
- Known hypersensitivity to opioids or any component of the study medications.
- Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
- Pregnancy or breastfeeding.
- Severe hepatic impairment (Child-Pugh class C).
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 |
|---|---|---|
| TegileridineTegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery. | Drug | Tegileridine Group |
| SufentanilSufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery. | Drug | Sufentanil Group |
| PalonosetronPalonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis. | Drug | Sufentanil Group, Tegileridine Group |
Primary outcome
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
Time frame: From 0 to 24 hours after admission to the PACU
The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU.
8 secondary outcomes
Resting and Movement Pain Intensity
Time frame: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
PCIA Demand and Effective Press Counts
Time frame: Within 48 hours after admission to the PACU.
Use of Rescue Analgesia
Time frame: Within 72 hours after admission to the PACU
Incidence and Severity of PONV
Time frame: Within 72 hours after admission to the PACU
Time to First Flatus
Time frame: From admission to the PACU until first passage of flatus, assessed up to 1 week.
Time to First Bowel Movement
Time frame: From admission to the PACU until first bowel movement, assessed up to 1 week.
Time to Resumption of Oral Intake
Time frame: From admission to the PACU until resumption of oral intake, assessed up to 1 week.
Length of Postoperative Hospital Stay
Time frame: From admission to the PACU until hospital discharge, assessed up to 30 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 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegileridine, Sufentanil and Palonosetron in people with Postoperative Pain, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 9 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: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jihong Jiang, MD (86-13482002227, jiangjihong@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU (time frame: From 0 to 24 hours after admission to the PACU). 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 10 Jun 2026.