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Efficacy and safety of mixture of liposomal bupivacaine and bupivacaine hydrochloride versus lidocaine injection for finger nerve block in emergency hand trauma: a multicenter, randomized controlled trial

Efficacy and safety of mixture of liposomal bupivacaine and bupivacaine hydrochloride versus lidocaine injection for finger nerve block in emergency hand trauma: a multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112889
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-11-26
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Open injury of the finger

Interventions

Experimental group:A mixture of liposomal bupivacaine injection (13.3 mg/mL) and bupivacaine hydrochloride (with a milligram dose ratio of 2:1 between liposomal bupivacaine injection and bupivacaine h
Control Group:A 1% lidocaine hydrochloride injection is used for digital nerve block.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or above, regardless of gender; 2. Patients with open finger injuries requiring emergency surgical repair under digital nerve block anesthesia; 3. Voluntary signing of informed consent; 4. Ability and willingness to participate in follow-up via text message or phone call.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of toxic reactions to local anesthesia; 2. Patients allergic to lidocaine or bupivacaine; 3. Patients with a history of drug abuse (anesthetics or alcohol) within the past 3 months; 4. Patients with chronic pain conditions (pain lasting more than 3 months); 5. Patients requiring emergency surgery on other parts of the hand besides the finger, where digital nerve block cannot meet anesthesia requirements; 6. Patients with contraindications for digital nerve block, such as tumors or local infections at the puncture site; 7. Patients with unstable systemic conditions, severe liver or kidney dysfunction, or coagulation disorders that preclude emergency surgery; 8. Patients with multiple systemic injuries; 9. Patients with psychiatric disorders; 10. Pregnant or breastfeeding women, or those with recent pregnancy plans; 11. Patients who refuse to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale (VAS) score at 2 days postoperatively;Changes from baseline of in ISI, PSQI, and EQ-VAS scores at 14 days postoperatively;Sleep quality within 14 days after surgery: Total sleep time, sleep latency, sleep efficiency, number of awakenings during the night, and sleep quality score within 14 days postoperatively.;

Secondary

MeasureTime frame
The amount of analgesic medication used within 14 days postoperatively. This includes the total dose of celecoxib capsules, the time of the first dose, and the duration of continuous use; as well as the MME (Morphine Milligram Equivalent) of opioid medications taken.;Onset time of anesthesia and duration of anesthesia;Visual Analog Scale (VAS) scores at 1, 3, 7, and 14 days postoperatively;

Countries

China

Contacts

Public ContactYun Qian

Shanghai Sixth People‘s Hospital

sakio@sjtu.edu.cn+86 21 6436 9181

Outcome results

None listed

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