Pain ManagementPhase 3NCT07844512
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
A Phase 3 study testing Tegileridine (tegileridine fumarate injection, IV) and Sufentanil in people with Pain Management and Overweight , Obesity, run by The First Hospital of Jilin University.
Trial summary
This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine. Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management, Overweight , Obesity, Respiration; Sleep Disorder
- What is being tested?
- Tegileridine (tegileridine fumarate injection, IV) and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Phase 3
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years old
- Scheduled for elective bariatric surgery
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Able to understand and complete the QoR-15 questionnaire
- Provide written informed consent to participate in the study
Who cannot join
- Known allergy or hypersensitivity to opioids, tegileridine or sufentanil
- Severe hepatic or renal dysfunction
- Preoperative chronic opioid use
- History of severe respiratory disease except obstructive sleep apnea
- Pregnant or breastfeeding women
- Participants who cannot complete postoperative follow-up
- Participation in another interventional clinical trial within 30 days before surgery
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: Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tapentadol in Patients Undergoing Bariatric Surgery
This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine.
Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA).
Read more
The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery.
There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.
- Being tested
- Tegileridine (tegileridine fumarate injection, IV), Sufentanil
- Medical subject headings
- Agnosia, Overweight, Obesity, Respiratory Aspiration, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegileridine (tegileridine fumarate injection, IV)Drug
Tegileridine will be given to participants for postoperative pain relief after bariatric surgery.
SufentanilDrug
Sufentanil, a standard opioid analgesic, will be given to participants to manage postoperative pain following bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tegileridine Group | Experimental | Not described Receives: Drug: Tegileridine (tegileridine fumarate injection, IV) |
| Standard Opioid Group | Active comparator | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery
The Quality of Recovery-15 (QoR-15) is a validated questionnaire used to assess the quality of postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score indicates a better quality of recovery.
Measured: 24 hours after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844512
- Sponsor's protocol ID
- 2026-HS-0043
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang T, Wang Y, Xie H, Wu Z, Yu S, Ou Y, Xu M, Jiang W, Ge L, Gao J, Wang Q, Gao H, Huang Y, Zhao P, Yu Y, Huang H, Ren J, Xia Z, Zhang J, Yu J, Chen X. Tegileridine for moderate-to-severe acute pain following abdominal surgery: A randomized, double-blind, phase 3 clinical trial. Cell Rep Med. 2025 Dec 16;6(12):102477. doi: 10.1016/j.xcrm.2025.102477. Epub 2025 Dec 8.
PubMed 41365300GBD 2021 Adult BMI Collaborators. Global, regional, and national prevalence of adult overweight and obesity, 1990-2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021. Lancet. 2025 Mar 8;405(10481):813-838. doi: 10.1016/S0140-6736(25)00355-1. Epub 2025 Mar 3.
PubMed 40049186