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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Tegileridine; Drug: Palonosetron; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jihong Jiang, MD; Phone Number: 86-13482002227; Email: jiangjihong@outlook.com
• Study Contact Backup: Name: Jie Xiao; Phone Number: 86-18353689295; Email: XiaoJie20220747@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegileridine Group; 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.	Drug: Tegileridine; Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.; Drug: Palonosetron; Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Active Comparator: Sufentanil Group; 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.	Drug: Palonosetron; Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.; Drug: Sufentanil; Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 0 to 24 hours after admission to the PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	From admission to the PACU until hospital discharge, assessed up to 30 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Inflammatory Biomarkers	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.	Before surgery and at predefined time points within 72 hours after admission to the PACU
Changes in I-FABP	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.	Before surgery and at predefined time points within 72 hours after admission to the PACU

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Quinuclidines; Fentanyl; Palonosetron; Sufentanil
• Other Study ID Numbers: IIT-CRU-FAMB-2026HS100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No