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The efficacy and safety of the tegileridine PCIA background infusion mode for postoperative analgesia in patients undergoing abdominal surgery

The efficacy and safety of the tegileridine PCIA background infusion mode for postoperative analgesia in patients undergoing abdominal surgery: A prospective clinical randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123455
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal tumors (liver tumors, gastrointestinal tumors)

Interventions

Background group:Tegilizidine PCIA Background Infusion Mode
Background-free group:Tegilitinib PCIA Background-Free Infusion Mode
Control group:Sufentanil PCIA Background Infusion Mode

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 75 years old, regardless of gender; 2.Body mass index (18kg/m^2 < BMI < 30kg/m^2); 3.Patients undergoing laparoscopic abdominal tumor surgery; 4.ASA classification I to III; 5.Have signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Chronic pain existed within one month before the surgery or any pain-relieving medication was being taken; 2.Allergic to opioid drugs; 3.History of drug and/or alcohol abuse within the past year; 4.Severe liver or kidney dysfunction (ALT and/or AST > 3 times the normal value, creatinine clearance rate < 30 mL/min), severe COPD (30% < FEV1 < 50%); 5.Long-term use of antipsychotic drugs by patients with mental disorders; 6.Currently pregnant or breastfeeding; 7.Withdrawal from PCIA or switch to other analgesic regimens; 8.The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Postoperative NRS scores (rest and activity);Postoperative patient satisfaction;

Secondary

MeasureTime frame
The time of first activation of the rescue analgesia plan after surgery and the number of rescue analgesia applications after surgery;Types and cumulative usage of postoperative rescue analgesic drugs;The consumption of PCIA drugs and Total number of PCIA presses and Number of effective PCIA compressions;Nauseous and Vomiting and swirl and Constipation;The first time one is able to get out of bed and move around and Time of anal gas expulsion;Ramsay Score;Self-assessment of sleep quality;SpO2 and Respiratory rate and Respiratory depression;Postoperative recovery quality score (QoR-15);Postoperative hospital stay;

Countries

China

Contacts

Public ContactXiong Zhangrong

Chongqing University Cancer Hospital

cqxzr0118@163.com+86 23 65075688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026