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Study on the efficacy and safety of Tegilidine for postoperative analgesia in patients with lower limb fractures: a prospective, randomized, double-blind controlled trial

Study on the efficacy and safety of Tegilidine for postoperative analgesia in patients with lower limb fractures: a prospective, randomized, double-blind controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117475
Enrollment
Unknown
Registered
2026-01-25
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

postoperative analgesia in patients with lower limb fractures

Interventions

M group:At the end of the operation (after the last suture was completed), 1mg of Taglidine fumarate injection was intravenously administered, and a patient-controlled intravenous analgesia pump for t
FL group:At the end of the operation (after the last suture was completed), 0.5mg of Taglidine fumarate injection was intravenously administered, and a patient-controlled intravenous analgesia pump fo
FH group:At the end of the operation (after the last suture was completed), 1mg of Taglidine fumarate injection was intravenously administered, and a patient-controlled intravenous analgesia pump for

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1Age between 18-80 years old, male and female; 2Subjects under elective general anaesthesia for lower limb fracture surgery, the expected duration of the operation 1h-4h, and the expected need for more than 48h of postoperative self-control intravenous analgesia pump treatment (moderate and severe pain); 3General anaesthesia for tracheal intubation, ASA anaesthesia classification ? - ?; 418kg/m^2<=body mass index (BMI) <=30kg/m^2; 5Subjects fully understand the purpose of this trial, the process and risks, and voluntarily signed an informed consent to participate in the clinical trial. = 30kg/m^2; 5. Subjects fully understood the purpose, content, process and risk of this trial, and voluntarily participated in the clinical trial and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to participate in the trial; 2. Patients who are allergic to the trial medication or who have had serious adverse reactions in the past; 3. Patients who have been taking sedative or analgesic medication for a long period of time prior to the procedure; 4. Those who are at a high risk of bronchial asthma or respiratory depression; 5. Patients who are unable to communicate due to hearing, vision, or speech disorders; 6. Patients who are combined with severe hepatic dysfunction (Child-Pugh class C); 7. Patients who are combined with severe renal dysfunction (requiring renal replacement therapy); 8. Patients with traumatic shock. Patients with severe renal dysfunction (requiring renal replacement therapy); 8. Patients with traumatic shock.

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale(NRS) scores at Rest and during Activity ;Percentage of subjects using rescue analgesics;

Secondary

MeasureTime frame
The incidence of moderate to severe nausea and vomiting within 48 hours after the operation;The time when analgesics are needed for the first time after the operation and the dosage of postoperative remedial opioids;The levels of white blood cells and C-reactive protein in the first postoperative blood routine test;

Countries

China

Contacts

Public ContactYu Wenli

Tianjin First Central Hospital

yzxyuwenli@163.com+86 139 2009 8326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026