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NCT Number: NCT07353996

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hanzhong, Zhejiang, 3100000, China

Location status: Recruiting

Location contact

yan min doctor

CONTACT

[email protected]

15888210247

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Single intravenous injection of Tegileridine Fumarate

Drug

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence and severity of postoperative nausea and vomiting (PONV)

    Time frame: From drug administration to 24 hours postoperatively

    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.

  2. Heart rate (HR)

    Time frame: From immediately before drug administration to 24 hours postoperatively

    Measured in beats per minute (bpm).

  3. Respiratory Rate (RR)

    Time frame: From immediately before drug administration to 24 hours postoperatively

    Measured in breaths per minute (bpm).

  4. Peripheral Oxygen Saturation (SpO₂)

    Time frame: From immediately before drug administration to 24 hours postoperatively

    Measured as a percentage (%).

  5. Extubation-related airway responses

    Time frame: From extubation until 10 minutes after extubation

    Incidence of airway reactions during emergence from anesthesia, including coughing and laryngospasm, assessed by the attending anesthesiologist at the time of tracheal extubation.

  6. Postoperative rescue analgesia requirement

    Time frame: From awakening to 24 hours postoperatively

    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).

  7. Patient-controlled analgesia (PCA) usage

    Time frame: From awakening to 24 hours postoperatively

    PCA usage parameters, including number of effective and total PCA button presses and total PCA-delivered opioid dose within 24 hours after surgery.

  8. Postoperative pain intensity (NRS scores)

    Time frame: 30 minutes, 6 hours, 12 hours, and 24 hours after awakening

    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.

  9. Incidence of postoperative adverse events

    Time frame: From drug administration to 24 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Yin Study Coordinator, Doctor

CONTACT

[email protected]

15888210247

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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