Skip to content

A randomized, double-blind, positive-controlled clinical study of tegilidine fumarate for postoperative analgesia after shoulder arthroscopy

A randomized, double-blind, positive-controlled clinical study of tegilidine fumarate for postoperative analgesia after shoulder arthroscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122201
Enrollment
Unknown
Registered
2026-04-10
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Postoperative analgesia in patients undergoing shoulder arthroscopy

Interventions

Experimental group:PCIA formula is tagilidine (specific concentration is set according to the preliminary pre-test results and drug package insert recommendations, currently 0.5 mg/mL is tentatively p
Control group:The PCIA formulation was HYDROmorphone hydrochloride (40µg/mL), and the background infusion, booster dose and lockout time were consistent with those of the test group.

Sponsors

People's Hospital of Ningxia Hui Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years, ASA class I-II; 2.Elective unilateral shoulder arthroscopic rotator cuff repair or Bankart repair; 3.PCIA analgesia required after surgery; 4.Informed consent signed

Exclusion criteria

Exclusion criteria: 1. Long-term opioid use (>=4 consecutive weeks); 2. Known allergy to opioids; 3. Severe liver and kidney dysfunction; 4. Patients with acute or severe bronchial asthma; 5. Patients with known or suspected gastrointestinal obstruction; 6. High risk of obstructive sleep apnea (STOP-Bang score >=3); 7.BMI>=30 kg/m^2; 8. Pregnancy or lactation; 9. Inability to cooperate with pain assessment or follow-up.

Design outcomes

Primary

MeasureTime frame
Area under the time-weighted curve of resting NRS score within 48 hours after surgery;Incidence of moderate to severe nausea and vomiting and respiratory depression within 48 hours after operation;

Secondary

MeasureTime frame
Rest and passive activity NRS scores at various time points after surgery;Interleukin-6 (IL-6) and C-reactive protein (CRP) levels;

Countries

China

Contacts

Public ContactZhi Yu

People's Hospital of Ningxia Hui Autonomous Region

yuzhi568@163.com+86 158 0960 3736

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026