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Efficacy and safety of Tajilidine in postoperative analgesia following laparoscopic colorectal cancer resection: a multicenter, prospective, randomized, double-blind controlled study

Efficacy and safety of Tajilidine in postoperative analgesia following laparoscopic colorectal cancer resection: a multicenter, prospective, randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125316
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Colorectal cancer

Interventions

Trial group:Fumarate Tegideridine injection: loading dose 1.0 mg + 0.05 mg, followed by administration via PCA pump, concentration 0.02 mg/mL, single effective push volume 2.5 mL, minimum interval bet
Control group:Morphine injection: loading dose 2 mg + 1 mg, followed by administration via PCA pump, concentration 0.4 mg/mL, single effective push volume 2.5 mL, minimum interval between two effectiv

Sponsors

Quzhou People Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Ages =18; 2. Patients undergoing laparoscopic colorectal cancer resection; 3. ASA I - II; 4. Body Mass Index (BMI) =18 kg/m^2 or =28 kg/m^2; 5. The patient voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of difficult airway; 2. Neurological disorders (e.g., depression) or epilepsy; 3. SpO211.1 mmol/L); 5. Severe hepatic impairment (Child-Pugh C); 6. Allergy or contraindication to opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or antiemetics; 7. Patients currently participating in or planning to participate in any interventional clinical trial.

Design outcomes

Primary

MeasureTime frame
Resting Sum of Pain Intensity Difference in 48hours;

Secondary

MeasureTime frame
Postoperative hospital stay;Record treatment-related adverse events (e.g., nausea, vomiting, respiratory depression, dizziness, and bradycardia);Record postoperative recovery (time to first flatus) for two groups of patients;Time of first getting out of bed;Cumulative dose and the proportion of subjects who did not receive rescue analgesia;Sum of pain intensity during exercise (aSPID48) (the degree of pain during an exercise state, such as during coughing);Time of first administration of rescue analgesic;

Countries

China

Contacts

Public ContactZheng Lihua

Quzhou People Hospital

qzzhenglh@163.com+86 570 3121425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026