Metacarpal fracture
Conditions
Interventions
Test group:Prior to closing the surgical incision, doctors administer 10 milliliters of liposomal bupivacaine (13.3 mg/mL) directly into the wound.
Control group:Prior to closing the surgical incision, doctors administer 10 milliliters of saline solution directly into the wound
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants must be at least 18 years old, with no gender restrictions; 2. Confirmed metacarpal fracture through X-ray imaging, requiring surgical treatment (open reduction and internal fixation); 3. Willing to provide written informed consent; 4. Available for follow-up communication via text or phone.
Exclusion criteria
Exclusion criteria: 1. Individuals who previously experienced adverse reactions to local anesthesia; 2. Those allergic to lidocaine or bupivacaine; 3. People with a history of narcotic or alcohol misuse in the last 3 months; 4. Sufferers of chronic pain (lasting over 3 months); 5. Patients who took opioid painkillers within 3 days before the procedure; 6. Cases where surgery was delayed beyond 7 days after injury; 7. Patients with additional fractures outside the metacarpal bones; 8. Those with accompanying nerve damage; 9. Individuals in poor general health, severe liver/kidney impairment, or blood clotting issues making surgery unsafe; 10. Diabetic patients with peripheral nerve complications; 11. People diagnosed with mental health conditions; 12. Expectant or nursing mothers, or women planning pregnancy soon; 13. Participants declining to join this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total pain intensity measured by VAS scores during the first 3 days after surgery (calculated as the area under the curve); | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative painkiller consumption during the first two weeks;Difference in VAS scores compared to baseline measurements;Postoperative mobility of finger joints (metacarpophalangeal and interphalangeal) in the affected limb (vs. the unaffected side);Changes in scores for the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and EQ Visual Analog Scale (EQ-VAS) compared to baseline measurements;Key sleep metrics measured within two weeks after surgery include total sleep duration, time taken to fall asleep (sleep onset latency), sleep efficiency, frequency of waking up at night, and overall sleep quality scores.; | — |
Countries
China
Contacts
Public ContactJialin Song
Shanghai Sixth People's Hospital
Outcome results
None listed