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The Role of the Novel Biased µ-Opioid Receptor Agonist Tegileridine Fumarate in Promoting Enhanced Recovery After Lumbar Spine Surgery: A Prospective Randomized Controlled Trial?

The Novel Biased µ-Opioid Receptor Agonist Tegileridine Fumarate Alleviates Inflammatory Pain: Mechanisms and Efficacy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122285
Enrollment
Unknown
Registered
2026-04-10
Start date
2026-04-10
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

Lumbar Disc Herniation? (LDH),Lumbar Vertebral Fracture?

Interventions

T Group (Tegileridine ):A loading dose of tegileridine 0.75 mg (5 mL) was administered 5 minutes before the end of surgery. The postoperative infusion pump solution was prepared as 0.9% normal saline
S Group (Sufentanil):A loading dose of sufentanil 3 µg was administered 5 minutes before the end of surgery. The postoperative patient-controlled analgesia infusion pump solution was prepared by mixin

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have undergone posterior lumbar surgery; 2. Age range: 18–65 years; 3. ASA I–II; 4. Agree to participate in the trial and sign the anesthesia informed consent form

Exclusion criteria

Exclusion criteria: 1. History of severe congenital heart disease, liver, or kidney disease; 2. Severe hearing or visual impairment; 3. Mental illness or cognitive impairment; 4. History of alcohol abuse; severe hepatic or renal impairment (Child-Pugh Class C or eGFR 3 months).

Design outcomes

Primary

MeasureTime frame
VAS scores at rest and during movement within 48 hours postoperatively.;

Secondary

MeasureTime frame
Postoperative recovery time points, including the time to first oral intake, time to first urination, time to first flatus, and time to first ambulation, were recorded.;PCA attempts;Incidence of postoperative nausea, vomiting, and respiratory depression;American Pain Society Pain Outcomes Questionnaire-Revised (APS-POQ-R);Patient recovery quality was assessed using the 15-item Quality of Recovery (QoR-15) questionnaire at 24 hours, 48 hours, and 1 week postoperatively.;

Countries

China

Contacts

Public ContactYiHan Wang

The Second Hospital of Lanzhou University

yihanwang11@163.com+86 136 6930 5355

Outcome results

None listed

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