The Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Amputee Patients

N/ANot Yet RecruitingNCT07783867

West China Hospital200 enrolled

Overview

This study aimes to evaluate whether perioperative intravenous lidocaine infusion effectively relieves postoperative pain, enhances recovery, and reduces chronic stump and phantom limb pain after amputation, thereby informing future multicenter trials and clinical guideline development.

Patients who meet the inclusion criteria are randomly allocated in a 1:1 ratio to the lidocaine or placebo group. Following induction of general anesthesia, the lidocaine group receives an intravenous bolus of 1.5 mg/kg (ideal body weight) over 10 minutes, followed by a continuous infusion at 1.5 mg/kg/hour until the end of surgery. The placebo group receives a matching volume of normal saline during the same period. For postoperative analgesia, the lidocaine group is provided with a lidocaine-containing intravenous patient-controlled analgesia (PCA) pump, and the placebo group receives a standard PCA pump.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Amputation

Interventions

Lidocaine Hydrochloride, InjectableDRUG

During anesthesia induction, intravenous lidocaine is administered at a dose of 1.5 mg/kg (based on ideal body weight) over 10 minutes. This is followed by a continuous infusion at 1.5 mg/kg/h until the end of surgery. Postoperative pain management involves the use of a patient-controlled intravenous analgesia (PCIA) device, which contains lidocaine 50 mg/kg (calculated based on ideal body weight, not exceeding 3500 mg), sufentanil 3 μg/kg (calculated based on ideal body weight for obese patients), and granisetron 12 mg, diluted to a total volume of 200 mL with 0.9% normal saline.

0.9% normal salineDRUG

In the placebo group, the same volume of normal saline is administered during anesthesia. The postoperative PCIA device contains sufentanil 3 μg/kg (calculated based on ideal body weight for obese patients) and granisetron 12 mg, diluted to a total volume of 200 mL with 0.9% normal saline.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1.Age 18-80 years; 2.Patients scheduled for elective or emergency primary above or below knee amputation (AKA or BKA) under general anesthesia; 3.American Society of Anesthesiologists (ASA) physical status I-III. The exclusion criteria. Exclusion Criteria: * 1\. Body weight \< 40 kg or \> 100 kg； 2. Cardiac conduction defects (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction \[LVEF\] \< 50%)； 3. Severe hepatic impairment (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or bilirubin levels \> 2.5 times the upper limit of normal) 4. Renal insufficiency (creatinine clearance \[CrCl\] \< 60 mL/min)； 5. Known allergy to the study drug； 6. Chronic opioid abuse； 7. Patients unable to communicate verbally.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

The primary outcome is the incidence of moderate-to-severe (NRS ≥4) movement-evoked pain (by turning over or moving the residual limb) at 24 h postoperatively

The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain

Time frame: The first 24 hours after surgery

Secondary Outcomes

Incidence of moderate-to-severe movement-evoked pain, assessed at 48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.

Time frame: At 48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier

The incidence of moderate to severe pain at rest ，assessed at 24、48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.

Time frame: At 24、48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.

Incidence of phantom limb pain during hospitalization

Phantom limb pain refers to painful sensations perceived in the absent limb, typically involving the distal portion, and may be described as burning, stabbing, throbbing, or cramping. Pain intensity at rest and during activity (e.g., turning over or moving the residual limb) is assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Neuropathic pain components are screened using the ID Pain tool, and the corresponding score is recorded.

Central Contacts

Chunling Jiang,, PhD

CONTACT

18980601096 jiangchunling@scu.edu.cn

Data from ClinicalTrials.gov

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