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NCT Number: NCT07637968

Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery

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.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Tegileridine

Drug

Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Sufentanil

Drug

Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Palonosetron

Drug

Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Resting and Movement Pain Intensity

    Time frame: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU

    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.

  2. PCIA Demand and Effective Press Counts

    Time frame: Within 48 hours after admission to the PACU.

    Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.

  3. Use of Rescue Analgesia

    Time frame: Within 72 hours after admission to the PACU

    The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.

  4. Incidence and Severity of PONV

    Time frame: Within 72 hours after admission to the PACU

    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.

  5. Time to First Flatus

    Time frame: From admission to the PACU until first passage of flatus, assessed up to 1 week.

    Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.

  6. Time to First Bowel Movement

    Time frame: From admission to the PACU until first bowel movement, assessed up to 1 week.

    Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.

  7. Time to Resumption of Oral Intake

    Time frame: From admission to the PACU until resumption of oral intake, assessed up to 1 week.

    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.

  8. Length of Postoperative Hospital Stay

    Time frame: From admission to the PACU until hospital discharge, assessed up to 30 days.

    Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.

Other outcomes

  1. Changes in Inflammatory Biomarkers

    Time frame: Before surgery and at predefined time points within 72 hours after admission to the PACU

    Serum levels of inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha), will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on systemic inflammatory response.

  2. Changes in I-FABP

    Time frame: Before surgery and at predefined time points within 72 hours after admission to the PACU

    Serum intestinal fatty acid-binding protein (I-FABP) levels will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on intestinal injury.

Study contacts

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

Jie Xiao

CONTACT

[email protected]

86-18353689295

Jihong Jiang, MD

CONTACT

[email protected]

86-13482002227

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial

Acronym: TASPER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 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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