An interventional study of Lidocaine Hydrochloride, Injectable and 0.9% normal saline in Amputation, sponsored by West China Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by West China Hospital · Not applicable, Interventional, and Treatment
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.
West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lidocaine Hydrochloride, Injectable
An equivalent volume of normal saline is administered during anesthesia and via the intravenous patient-controlled analgesia (PCA) pump postoperatively.
Drug: 0.9% normal saline
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.
Also known as: Lidocaine group
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.
Also known as: placebo group
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
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.
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: 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.
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: 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.
Time frame: Duration of hospital stay, an expected average of 7 days
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.
Intraoperative and postoperative opioids use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
Time frame: At 24, 48 and 72 hours postoperatively，and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.
The incidence of PONV during the first 24 hours after surgery
we considered it PONV if patients felt any nausea or had any vomiting
Time frame: At 24 hours after surgery]
Recovery quality 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
Time frame: At 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.
Bowel function recovery
defined as the time to first defecation or time to first flatus
Time frame: Duration of hospital stay, an expected average of 7 days
Incidence of residual limb pain and phantom limb pain 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.
Time frame: At 6 months and 1 year postoperatively
Quality of life at 6 months and 1 year postoperatively
Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score
Time frame: At 6 months and 1 year postoperatively
Sleep quality at 6 months and 1 year postoperatively
Assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: At 6 months and 1 year postoperatively
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine