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Effect of patient-controlled intravenous analgesia with tegileridine on postoperative pain and recovery after mastectomy

Effect of patient-controlled intravenous analgesia with tegileridine on postoperative pain and recovery after mastectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124027
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Postoperative pain

Interventions

Sufentanil group:Postoperative patient-controlled intravenous analgesic pump(Sufentanil 80µg+0.9%NS=80ml, concentration 1µg/ml, PCIA dose 3µg, lock time 30min).
Tegiletidine group:Postoperative patient-controlled intravenous analgesia pump (tegiletidine 4mg+0.9%NS=80ml, concentration 0.05mg/ml, PCIA dose 0.15mg, lock time 30min)

Sponsors

Foshan Nanhai District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Elective mastectomy under general anesthesia. 2. Aged 18~65. 3. Female. 4. BMI 18~25 kg/m². 5. ASA physical status from 1 to 3. 6. Signing the informed consent form for the trial.

Exclusion criteria

Exclusion criteria: 1. Long-term use of opioid drugs or addiction, or allergy to opioids or any component of this product; 2. Emergency surgery; 3. Preoperative psychiatric disorders or severe anxiety; 4. Consciousness disorders, severe visual, auditory, or speech communication impairments; 5. Severe liver and kidney dysfunction and other systemic diseases; 6. Allergy to drugs used during anesthesia; 7. Pregnant or breastfeeding patients; 8. Patients with acute or severe bronchial asthma; 9. Known or suspected gastrointestinal obstruction.

Design outcomes

Primary

MeasureTime frame
Quality of recovery-15(QoR-15);

Secondary

MeasureTime frame
postoperative pain intensity:VAS;The number of total presses of PCA within postoperative 48 hours.;

Countries

China

Contacts

Public ContactPing Mo

Foshan Nanhai District People's Hospital

pop_pan@126.com+86 139 2866 5645

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026