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Recruiting NCT06405776

Effect of Lidocaine on Postoperative Pain and Long-term Survival in Elderly Patients Undergoing Colorectal Surgery

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lidocaine, Placebo.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain and Long-term Survival in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial

Overview

This study is a further observation and follow-up of the patients enrolled in the registration number NCT05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery.

Detailed description

This study is a further observation and follow-up of the patients enrolled in the registration number NCT05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery. Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine group, lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole procedure. Postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200mL in 0.9% normal saline solution with a total volume of 200mL.Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.

Interventions

  • Drug lidocaine
    Patients in the lidocaine group, lidocaine 1.5mg/kg/h is continuously infused (using ideal body weight) during the whole procedure, postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery.
  • Drug Placebo
    In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.

Primary outcome measures

  • The incidence of chronic pain at 3 months postoperatively [Time frame: 3 months postoperatively]
Secondary outcome measures (6)
  • The incidence of chronic pain at 6 months ,1 year, 3 years and 5 years postoperatively [Time frame: 6 months, 1 year and 3 years postoperatively]
  • Overall survival after surgery [Time frame: 6 months, 1 year, 3 years, 5 years postoperatively]
  • Recurrence-free survival after surgery [Time frame: 6 months, 1 year, 3 years, 5 years postoperatively]
  • Disability-free surviva survival [Time frame: 6 months, 1 year, 3 years, 5 years postoperatively]
  • The prevalence of neuropathic pain [Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively]
  • Brief Pain Inventory(BPI) pain interference subscale score [Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively]

Eligibility criteria

Inclusion criteria

  • Participants were at least 60 years old;
  • American Society of Anesthesiologists (ASA) physical status I to III;
  • Body-mass index of 18-30 kg/m2;
  • Scheduled for elective colorectal surgery.

Exclusion criteria

  • Metastases occurring in other distant organs;
  • Severe hepatic insufficiency (aspartate aminotransferase or alaninetransaminase or bilirubin >2.5 times the upper limit of normal);
  • Renal impairment (creatinine clearance <60 mL/min);
  • Cardiac rhythm disorders or systolic heart failure (second-and thirddegree heart block, ejection fraction <50%);
  • Allergies to any of the trial drugs; chronic opioid use;
  • Inability to comprehend numeric rating scale.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • China — Sichuan

Identifiers

NCT: NCT06405776 · 2020HX1180-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗