Amputation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUG0.9% normal saline
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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| Incidence of phantom limb pain during hospitalization | 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. |
| 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. | 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 |
| The incidence of PONV during the first 24 hours after surgery | At 24 hours after surgery] | we considered it PONV if patients felt any nausea or had any vomiting |
| Recovery quality at 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier. | 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 |
| Bowel function recovery | Duration of hospital stay, an expected average of 7 days | defined as the time to first defecation or time to first flatus |
| Incidence of residual limb pain and phantom limb pain at 6 months and 1 year postoperatively | 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. |
| Quality of life at 6 months and 1 year postoperatively | At 6 months and 1 year postoperatively | Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score |
| Sleep quality at 6 months and 1 year postoperatively | At 6 months and 1 year postoperatively | Assessed using the Pittsburgh Sleep Quality Index (PSQI) |
Countries
China
Contacts
CONTACTChunling Jiang,, PhD
Outcome results
None listed