Analgesic effect of perioperative intravenous lidocaine infusion for oral cancer resection and free flap reconstruction: a single-center, parallel, randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088614

Enrollment

Unknown

Registered

2024-08-22

Start date

2024-08-22

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

oral cancer

Interventions

Experimental:Calculated on the basis of ideal body weight, a loading dose of 1.5 mg/kg lidocaine was administered at the induction of general anesthesia, followed by a continuous infusion at 1 mg/kg/h

Control group:Calculated on the basis of ideal body weight, a loading dose of 1.5 mg/kg 0.9% saline was administered at the induction of general anesthesia, followed by a continuous infusion at 1 mg/k

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 (2) ASA?-? (3) Plan to have oral cancer resection and free flap reconstruction under general anesthesia (4) Sign or be able to provide informed consent

Exclusion criteria

Exclusion criteria: (1) Complicated other malignant tumors or metastatic lesions in other organs (2) Severe hepatic insufficiency (3) Severe renal insufficiency (4) Arrhythmia or systolic heart failure (5) Uncontrolled epilepsy (6) Preoperative history of chronic pain, analgesic or sedative abuse (7) Unable to understand the pain numeric rating scale (8) Known allergy to any of the test drugs (9) Participated in a clinical trial of another drug or medical device in the last 3 months

Design outcomes

Primary

Measure	Time frame
Cumulative opioid consumption within 24 hours after surgery;	—

Secondary

Measure	Time frame
Intraoperative opioid consumption;NRS scores at 24, 48, and 72 hours postoperatively;Incidence of moderate to severe pain (NRS =4) at 24, 48, and 72 hours postoperatively;Nausea and vomiting scores at 24, 48, and 72 hours postoperatively;Lidocaine-related adverse events ;Surgery-related adverse events;Recovery time of gastrointestinal function in the first three postoperative days;Length of hospitalization;Incidence of chronic pain at 3 months postoperatively;Incidence of neuropathic pain at 3 months postoperatively;Tumor recurrence rate at 3 months after surgery;	—

Measure

Time frame

Intraoperative opioid consumption;NRS scores at 24, 48, and 72 hours postoperatively;Incidence of moderate to severe pain (NRS =4) at 24, 48, and 72 hours postoperatively;Nausea and vomiting scores at 24, 48, and 72 hours postoperatively;Lidocaine-related adverse events ;Surgery-related adverse events;Recovery time of gastrointestinal function in the first three postoperative days;Length of hospitalization;Incidence of chronic pain at 3 months postoperatively;Incidence of neuropathic pain at 3 months postoperatively;Tumor recurrence rate at 3 months after surgery;

—

Countries

China

Contacts

Public ContactWangyuan Zou

Xiangya Hospital Central South University

wangyuanzou@csu.edu.cn+86 180 7313 7075

Outcome results

None listed

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