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Study on the analgesic effect of bupivacaine liposome transperitoneal nerve block after lower limb orthopedic surgery in children

Study on the analgesic effect of bupivacaine liposome transperitoneal nerve block after lower limb orthopedic surgery in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122919
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Analgesic effect after lower limb orthopedic surgery in children

Interventions

Bupivacaine hydrochloride group:After anesthesia induction, peripheral nerve block was performed under ultrasound guidance with 0.25% bupivacaine. A single dose of 5mg/kg was administered, and the tot
Bupivacaine liposome group:After anesthesia induction, peripheral nerve block was performed under ultrasound guidance with 0.665% liposomal bupivacaine liposomes. A single dose of 3mg/kg was administe

Sponsors

Hunan Children’ Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. 6 years old <=age age <=17 years old 2. ASAI or Grade II 3. BMI: 18 kg/m^2 <BMI <30 kg/m^2 4. Selective orthopedic surgery for lower limbs 5. Plan to undergo nerve block 6. Postoperative planning to use PCIA for analgesics 7. Parents or guardians sign informed consent form and are able to follow the research plan

Exclusion criteria

Exclusion criteria: 1. There are previous neurological diseases that affect pain perception or anesthesia, such as epilepsy, spinal cord injury, peripheral nerve injury, etc 2. Contraindications of general anesthesia or nerve block 3. Use opioids within 1 month before the operation; long-term opioid use history (more than 1 month) 4. Patients with mental or cognitive impairment who cannot follow the study protocol 5. Patients who are allergic to bupivacaine liposomes or bupivacaine hydrochloride or contraindications 6. History of chronic pain 7. There are serious comorbidities in preoperative evaluation 8. Other diseases that may interfere with the study results 9. Those who were transferred to ICU treatment after surgery

Design outcomes

Primary

MeasureTime frame
NRS-AUC Pain Score within 72 hours after anesthesia;

Secondary

MeasureTime frame
Morphine consumption equivalent within 72 hours after surgery;Comprehensive pain index and opioid consumption score within 72 hours of postoperative surgery;The incidence of moderate to severe pain within 72 hours after surgery;Adverse Event Rate;

Countries

China

Contacts

Public ContactWei Siwei

Hunan Children’ Hospital

wsw769850382@163.com+86 185 8885 7577

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026