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A Multicenter, Randomized, Controlled Study on the Efficacy of Postoperative Analgesia and Early Recovery Quality of Liposomal Bupivacaine after Ankle Fracture Surgery

A Multicenter, Randomized, Controlled Study on the Efficacy of Postoperative Analgesia and Early Recovery Quality of Liposomal Bupivacaine after Ankle Fracture Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099333
Enrollment
Unknown
Registered
2025-03-21
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

postoperative pain

Interventions

liposomal bupivacaine group:Nerve block was performed using 30 ml of 0.665% liposomal bupivacaine: 20 ml for sciatic nerve block at the popliteal fossa and 10 ml for saphenous nerve block in the adduc
Ropivacaine group:Nerve block was carried out using 30 ml of 0.375% ropivacaine: 20 ml for sciatic nerve block at the popliteal fossa and 10 ml for saphenous nerve block in the adductor canal.

Sponsors

Gansu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria and have a fracture type of bimalleolar or trimalleolar fracture; (2) Patients aged between 18 and 75 years old, with ASA grade I- II; (3) Patients who voluntarily accept nerve block treatment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating patients; (2) Patients complicated with peripheral nerve injury or lesion; (3) Patients with a previous history of specific allergic diseases (such as asthma, urticaria, eczema, etc.) or known allergies to anesthetic drugs; (4) Patients suffering from mental disorders, epilepsy, or having intellectual abnormalities; (5) Patients with inflammation, ulcers, scars, or damage around the skin at the site where nerve block is to be administered; (6) Patients with a history of long-term use of analgesic drugs or a history of alcohol abuse; (7) Patients with a previous history of chronic neuropathic pain.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Score;

Secondary

MeasureTime frame
The time of the first administration of analgesic drugs within 72 hours and the total consumption of analgesic drugs;Quality of Postoperative Recovery Score;The incidence rate of nausea and vomiting after the operation;

Countries

China

Contacts

Public ContactXue Jianjun

Gansu Provincial Hospital of Traditional Chinese Medicine

xjjfei419@126.com+86 150 0256 2503

Outcome results

None listed

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