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

NCT07783867 | Not Yet Recruiting

• 1 other identifier: 2022-1327
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

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

  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 first 24 hours after surgery

Secondary Outcomes (10)

• 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 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.

• Incidence of phantom limb pain during hospitalization

  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.

  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

  At 24 hours after surgery]

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

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.

Also known as: Lidocaine group

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.

Also known as: placebo group

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Lidocaine; Injections; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Chunling Jiang,, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: West China Hospital, Sichuan University

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)