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NCT Number: NCT07783867

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

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.

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Key information

Conditions

Amputation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location contact

Fengming Luo, PhD

CONTACT

[email protected]

02885423593

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine Hydrochloride, Injectable

Drug

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.

Other names: Lidocaine group

0.9% normal saline

Drug

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.

Other names: placebo group

Primary outcomes

  1. 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

    Time frame: The first 24 hours after surgery

    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

Secondary outcomes

  1. 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 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.

  2. 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.

    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.

  3. Incidence of phantom limb pain during hospitalization

    Time frame: Duration of hospital stay, an expected average of 7 days

    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.

  4. The cumulative morphine consumption 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.

    Intraoperative and postoperative opioids use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator

  5. The incidence of PONV during the first 24 hours after surgery

    Time frame: At 24 hours after surgery]

    we considered it PONV if patients felt any nausea or had any vomiting

  6. Recovery quality at 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.

    Time frame: At 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.

    Quality of Recovery-15 (QoR-15) scores

  7. Bowel function recovery

    Time frame: Duration of hospital stay, an expected average of 7 days

    defined as the time to first defecation or time to first flatus

  8. Incidence of residual limb pain and phantom limb pain at 6 months and 1 year postoperatively

    Time frame: At 6 months and 1 year postoperatively

    Residual limb pain is localized to the surgical site and is predominantly nociceptive, often described as sharp. 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. For both types, the location and severity are documented. 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.

  9. Quality of life at 6 months and 1 year postoperatively

    Time frame: At 6 months and 1 year postoperatively

    Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score

  10. Sleep quality at 6 months and 1 year postoperatively

    Time frame: At 6 months and 1 year postoperatively

    Assessed using the Pittsburgh Sleep Quality Index (PSQI)

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Jiang,, PhD

CONTACT

[email protected]

18980601096

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Patients Undergoing Amputation

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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