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The effect of tegileridine on acute pain after total hysterectomy

The effect of tegileridine on acute pain after laparoscopic total hysterectomy: A randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126560
Enrollment
Unknown
Registered
2026-06-11
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Postoperative acute pain

Interventions

Tegileridine group:10 minutes after the patient was extubated, a loading dose of tegretol was started to be pumped. 1 mg of tegretol was diluted to 10 ml, with a pumping rate of 60 ml/h. The pumping w
Oxycodone group:10 minutes after the patient was extubated, the loading dose of oxycodone (3 mg) was started to be pumped. The oxycodone was diluted to 10 ml, with a pumping rate of 60 ml/h. The pumpi
Placebo group:10 minutes after the patient was extubated, the loading dose placebo was started to be pumped. 10 ml of NS was prepared and pumped at a rate of 60 ml/h. The pumping was completed within

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-65 years (inclusive of both ends); 2. ASA grades I-III; 3. Patients scheduled for elective laparoscopic total hysterectomy.

Exclusion criteria

Exclusion criteria: 1. Sleep apnea syndrome, with severe respiratory depression and pulse oxygen saturation 40 kg/m2); 4. Patients with a history of mental illness or cognitive impairment who cannot cooperate with the assessment; 5. Patients with moderate to severe liver or kidney dysfunction; 6. Patients with chronic pain history who have been taking analgesic drugs for a long time; 7. Patients who are allergic to opioids or any component of this product; 8. Patients with severe coagulation dysfunction; 9. Patients who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
The total difference in pain intensity at rest over the period from the start of administration of the loading dose to 24 hours (SPID24);

Secondary

MeasureTime frame
Resting SPID and exercise SPID at 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the loading dose;The total pain relief scores (TOTPAR) at rest and during exercise at 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the loading dose;The first time to press the PCIA button;The time of first administration of analgesic rescue medication;The cumulative amount (calculated in terms of morphine equivalent) and the number of cases of rescue medication within 0 to 24 hours;QoR-15 on the 1st and 2nd days after surgery;Opioid-related adverse events (ORADEs);The first exhaust time and the time for getting out of bed and moving around;

Countries

China

Contacts

Public ContactRong Ma

The First Affiliated Hospital of Nanjing Medical University

mrongerr@163.com+86 138 5156 1882

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026