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

Sponsor
West China Hospital
Study ID
NCT07783867
Status
Not Yet Recruiting

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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lidocaine group
    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, and subsequently by a lidocaine-containing intravenous patient-controlled analgesia pump for postoperative pain management.
  • Placebo Comparator: placebo group
    An equivalent volume of normal saline is administered during anesthesia and via the intravenous patient-controlled analgesia (PCA) pump postoperatively.

Primary Outcome Measure

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 ]

Central Contacts

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