Postoperative PainPhase 4NCT07353996
Determination of the Effective Dose of a Single Intravenous Dose of Tegileridine Fumarate for Postoperative Analgesia After Orthopedic Surgery: A Up-and-Down Sequential Allocation Study
A Phase 4 study testing Single intravenous injection of Tegileridine Fumarate in people with Postoperative Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to determine the 90% effective dose (ED90) of a single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing orthopedic surgery, including spinal… 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?
- Single intravenous injection of Tegileridine Fumarate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2025to 1 May 2026
- 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
- Adults aged 18 to 75 years.
- Scheduled for elective orthopedic surgery, including spinal fusion, femoral fracture fixation, or total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Patients with moderate to severe obesity (BMI > 30 kg/m²).
- Known hypersensitivity or allergy to tegileridine fumarate or other analgesics.
- History of chronic pain or long-term use of opioids.
- Severe hepatic or renal impairment.
- Patients requiring postoperative ICU care.
- Severe respiratory depression (e.g., oxygen saturation < 90%).
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
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
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hanzhong, Zhejiang, 3100000
yan min doctor, 15888210247, zryanmin@zju.edu.cn
About this study
The goal of this clinical trial is to determine the 90% effective dose (ED90) of a single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing orthopedic surgery, including spinal fusion surgery, femoral fracture fixation, and total knee arthroplasty.
The main questions this study aims to answer are:
Read more
What is the ED90 of a single intravenous dose of tegileridine fumarate for achieving adequate postoperative analgesia, defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesia?
Participants will:
Receive a single intravenous injection of tegileridine fumarate during skin closure at the end of surgery.
Start with an initial dose of 0.5 mg, with subsequent doses adjusted upward or downward in 0.1 mg increments for the next participant based on the analgesic response of the preceding participant, following a biased-coin up-and-down sequential dose allocation design.
Be closely monitored during the postoperative recovery period for pain intensity, vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation), and adverse reactions such as nausea, vomiting, respiratory depression, agitation, and other opioid-related side effects.
This study aims to identify an optimal single-dose regimen of tegileridine fumarate that provides effective postoperative analgesia with an acceptable safety profile, thereby improving postoperative pain control and promoting enhanced recovery in patients undergoing orthopedic surgery.
- Conditions
- Postoperative Pain
- Being tested
- Single intravenous injection of Tegileridine Fumarate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intravenous injection of Tegileridine FumarateDrug
Single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients (18-75 years, ASA I-III) undergoing orthopedic surgery, including spinal fusion, femoral fracture fixation, and total knee arthroplasty. The study uses a dose-escalation design to determine the 90% effective dose (ED90).
Doses: To be determined using an up-and-down sequential allocation method (dose-ranging study).
| Study group | Role | What they receive |
|---|---|---|
| Single intravenous Tegileridine Fumarate arm | Experimental | Not described Receives: Drug: Single intravenous injection of Tegileridine Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective dose producing adequate postoperative analgesia in 90% of patients (ED90)
The primary outcome was the 90% effective dose (ED90) of a single intravenous bolus of tegileridine for postoperative analgesia following orthopedic surgery. Analgesic success was defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesics.
Dose allocation followed a biased-coin up-and-down sequential design, with dose adjustments based on the analgesic response of the preceding patient. The ED90 and its 90% confidence interval were estimated using isotonic regression analysis.
Measured: Within 30 minutes after awakening from anesthesia
Secondary outcomes (9)
Incidence and severity of postoperative nausea and vomiting (PONV)
The incidence and severity of postoperative nausea and vomiting (PONV) within 24 hours after administration of tegileridine were assessed. PONV was evaluated by trained clinical staff using a standardized ordinal severity scale, defined as:
0 = no nausea or vomiting;
- = nausea only;
- = retching (dry heaves);
- = vomiting.
Measured: From drug administration to 24 hours postoperatively
Heart rate (HR)
Measured in beats per minute (bpm).
Measured: From immediately before drug administration to 24 hours postoperatively
Respiratory Rate (RR)
Measured in breaths per minute (bpm).
Measured: From immediately before drug administration to 24 hours postoperatively
Peripheral Oxygen Saturation (SpO₂)
Measured as a percentage (%).
Measured: From immediately before drug administration to 24 hours postoperatively
Extubation-related airway responses
Incidence of airway reactions during emergence from anesthesia, including coughing and laryngospasm, assessed by the attending anesthesiologist at the time of tracheal extubation.
Measured: From extubation until 10 minutes after extubation
Postoperative rescue analgesia requirement
Use of rescue analgesia after surgery, including whether additional opioid analgesics were required within 30 minutes after awakening and cumulative opioid consumption within 24 hours postoperatively (converted to morphine equivalents).
Measured: From awakening to 24 hours postoperatively
Patient-controlled analgesia (PCA) usage
PCA usage parameters, including number of effective and total PCA button presses and total PCA-delivered opioid dose within 24 hours after surgery.
Measured: From awakening to 24 hours postoperatively
Postoperative pain intensity (NRS scores)
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain) at rest and during movement at predefined postoperative time points.
Measured: 30 minutes, 6 hours, 12 hours, and 24 hours after awakening
Incidence of postoperative adverse events
Incidence of adverse events, including agitation (Richmond Agitation-Sedation Scale ≥2), delirium (Nu-DESC score ≥2), respiratory depression (SpO₂ <90%), delayed emergence, pruritus, dizziness, shivering, and postoperative nausea and vomiting (PONV), graded according to severity.
Measured: From drug administration to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start25 Oct 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (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 Second Affiliated Hospital, Zhejiang 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353996
- Sponsor's protocol ID
- 2025-0393
- Status last verified
- Oct 2025
- First submitted
- 24 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effective Dose of a Single Intravenous Dose of Tegileridine Fumarate for Postoperative Analgesia After Orthopedic Surgery: A Up-and-Down Sequential Allocation Study
- ClinicalTrials.gov ID
- NCT07353996
- Acronym / sponsor ID
- 2025-0393
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 21 Jan 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.
The goal of this clinical trial is to determine the 90% effective dose (ED90) of a single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing orthopedic surgery, including spinal fusion surgery, femoral fracture fixation, and total knee arthroplasty.
The main questions this study aims to answer are:
What is the ED90 of a single intravenous dose of tegileridine fumarate for achieving adequate postoperative analgesia, defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesia?
Participants will:
Receive a single intravenous injection of tegileridine fumarate during skin closure at the end of surgery.
Start with an initial dose of 0.5 mg, with subsequent doses adjusted upward or downward in 0.1 mg increments for the next participant based on the analgesic response of the preceding participant, following a biased-coin up-and-down sequential dose allocation design.
Be closely monitored during the postoperative recovery period for pain intensity, vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation), and adverse reactions such as nausea, vomiting, respiratory depression, agitation, and other opioid-related side effects.
This study aims to identify an optimal single-dose regimen of tegileridine fumarate that provides effective postoperative analgesia with an acceptable safety profile, thereby improving postoperative pain control and promoting enhanced recovery in patients undergoing orthopedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single intravenous Tegileridine Fumarate arm | Experimental | Drug: Single intravenous injection of Tegileridine Fumarate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 75 years.
- Scheduled for elective orthopedic surgery, including spinal fusion, femoral fracture fixation, or total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (7 listed)
- Patients with moderate to severe obesity (BMI > 30 kg/m²).
- Known hypersensitivity or allergy to tegileridine fumarate or other analgesics.
- History of chronic pain or long-term use of opioids.
- Severe hepatic or renal impairment.
- Patients requiring postoperative ICU care.
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 |
|---|---|---|
| Single intravenous injection of Tegileridine FumarateSingle intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients (18-75 years, ASA I-III) undergoing orthopedic surgery, including spinal fusion, femoral fracture fixation, and total knee arthroplasty. The study uses a dose-escalation design to determine the 90% effective dose (ED90). Doses: To be determined using an up-and-down sequential allocation method (dose-ranging study). | Drug | Single intravenous Tegileridine Fumarate arm |
Primary outcome
Effective dose producing adequate postoperative analgesia in 90% of patients (ED90)
Time frame: Within 30 minutes after awakening from anesthesia
The primary outcome was the 90% effective dose (ED90) of a single intravenous bolus of tegileridine for postoperative analgesia following orthopedic surgery. Analgesic success was defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesics. Dose allocation followed a biased-coin up-and-down sequential design, with dose adjustments based on the analgesic response of the preceding patient. The ED90 and its 90% confidence interval were estimated using isotonic regression analysis.
9 secondary outcomes
Incidence and severity of postoperative nausea and vomiting (PONV)
Time frame: From drug administration to 24 hours postoperatively
Heart rate (HR)
Time frame: From immediately before drug administration to 24 hours postoperatively
Respiratory Rate (RR)
Time frame: From immediately before drug administration to 24 hours postoperatively
Peripheral Oxygen Saturation (SpO₂)
Time frame: From immediately before drug administration to 24 hours postoperatively
Extubation-related airway responses
Time frame: From extubation until 10 minutes after extubation
Postoperative rescue analgesia requirement
Time frame: From awakening to 24 hours postoperatively
Patient-controlled analgesia (PCA) usage
Time frame: From awakening to 24 hours postoperatively
Postoperative pain intensity (NRS scores)
Time frame: 30 minutes, 6 hours, 12 hours, and 24 hours after awakening
Incidence of postoperative adverse events
Time frame: From drug administration to 24 hours 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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single intravenous injection of Tegileridine Fumarate in people with Postoperative Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 7 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 21 Jan 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.
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 Min Yin Study Coordinator, Doctor (15888210247, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dose producing adequate postoperative analgesia in 90% of patients (ED90) (time frame: Within 30 minutes after awakening from anesthesia). 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 21 Jan 2026.