Use of bupivacaine Liposome Injection for nerve block in free fibular flap transfer for maxillofacial surgery to reduce perioperative opioid usage and promote enhanced recovery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080944

Enrollment

Unknown

Registered

2024-02-19

Start date

2024-03-01

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

None listed

Interventions

Bupivacaine Group:Ultrasound guided popliteal sciatic nerve block using bupivacaine liposome injection before surgery.

Control Group:Disinfect and lay towels only, do not perform puncture injections.

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years but <80 years. 2) Scheduled to undergo elective oral and maxillofacial surgery with free fibular flap reconstruction. 3) Provide written informed consents.

Exclusion criteria

Exclusion criteria: 1) Infection at the puncture site. 2) Severe coagulation dysfunction. 3) History of local anesthetic allergy. 4) History of severe mental disorders, or uncooperative patients. 5) ASA classification = III. 6) Participate in other clinical studies. 7) Refuse to sign informed consent form.

Design outcomes

Primary

Measure	Time frame
The total dose of opioids used.;	—

Secondary

Measure	Time frame
Incidence of moderate to severe pain at different stages after surgery.;Incidence of moderate to severe pain within 48 hours after surgery.;Incidence of postoperative nausea and vomiting within 48 hours after surgery.;Subjective sleep quality within 2 days after surgery.;Length of stay in hospital after surgery.;Incidence of in-hospital complications after surgery.;Incidence of in-hospital mortality after surgery.;	—

Measure

Time frame

Incidence of moderate to severe pain at different stages after surgery.;Incidence of moderate to severe pain within 48 hours after surgery.;Incidence of postoperative nausea and vomiting within 48 hours after surgery.;Subjective sleep quality within 2 days after surgery.;Length of stay in hospital after surgery.;Incidence of in-hospital complications after surgery.;Incidence of in-hospital mortality after surgery.;

—

Countries

China

Contacts

Public ContactYang Xudong

Peking university school and hospital of stomatology

kqyangxudong@163.com+86 10 8219 5287

Outcome results