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A Study Comparing Tegileridine and Morphine for Pain Control After Lower Extremity Fracture Surgery

Efficacy of Tegileridine Versus Morphine in Preventing Rebound Pain Following Peripheral Nerve Block in Patients Undergoing Surgery for Lower Extremity Fractures: A Prospective, Randomized, Double-Blind, Active-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128912
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-07-28
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Rebound pain after peripheral nerve block

Interventions

Tegileridine group:Tegileridine-based PCIA
Morphine group:Morphine-based PCIA

Sponsors

The First Affiliated Hospital of the University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–65 years, either sex; 2.American Society of Anesthesiologists (ASA) physical status I–III; 3.Scheduled for unilateral lower extremity fracture open reduction and internal fixation with single-shot peripheral nerve block; 4.Planned use of postoperative intravenous patient-controlled analgesia within 48 hours; 5.Willing to participate and sign informed consent;

Exclusion criteria

Exclusion criteria: 1.Planned continuous peripheral nerve block; 2.Allergy or contraindication to study drugs; 3.History of chronic pain; 4.Multiple trauma patients; 5.Use of opioids, sedatives, antipsychotics, muscle relaxants, anxiolytics or alcohol within 1 week; 6.History of drug or alcohol abuse or dependence; 7.CYP2D6 poor metabolizers or relevant inhibitor use; 8.CYP3A4 strong inhibitor or inducer use; 9.Adrenal insufficiency or long-term steroid use; 10.Severe hepatic impairment (Child-Pugh class C); 11.Uncontrolled severe cardiovascular, respiratory, neurological or psychiatric disease; 12.Pregnancy or lactation; 13.Any condition deemed unsuitable by investigators;

Design outcomes

Primary

MeasureTime frame
Incidence of rebound pain after peripheral nerve block;

Secondary

MeasureTime frame
Summed Pain Intensity Difference (SPID);Number of PCIA demands;Incidence of adverse events;Rescue analgesic use;Patient satisfaction with analgesia;

Countries

China

Contacts

Public ContactWei Gao

The First Affiliated Hospital of the University of Science and Technology of China

weigao_mz@ustc.edu.cn+86 551 6228 2131

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026