Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06405776

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

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.

Placebo

Drug

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 outcomes

  1. The incidence of chronic pain at 3 months postoperatively

    Time frame: 3 months postoperatively

    Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.

Secondary outcomes

  1. 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

    Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.

  2. Overall survival after surgery

    Time frame: 6 months, 1 year, 3 years, 5 years postoperatively

    Overall survival is defined as the time between the date from surgery to the date of death.

  3. Recurrence-free survival after surgery

    Time frame: 6 months, 1 year, 3 years, 5 years postoperatively

    Postoperative re-examination is based on the diagnosis of enhanced CT, MRI, ultrasound or blood examination to determine whether the patient has recurrence and metastasis. Recurrence-free time refers to the time from surgery to tumor recurrence based on the above CT, MRI, etc.

  4. Disability-free surviva survival

    Time frame: 6 months, 1 year, 3 years, 5 years postoperatively

    Patient self-assessment is carried out by using the World Health Organization(WHO) Disability Scale, with a minimum score of 12 points and a maximum score of 60 points. The lower the score, the higher the quality of life.

  5. The prevalence of neuropathic pain

    Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively

    The ID Pain scale is used as a validated assessment of neuropathic pain. ID pain questionnaire consists of six items. Pain higher scores suggest a neuropathic component to the pain.

  6. Brief Pain Inventory(BPI) pain interference subscale score

    Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively

    BPI pain interference subscale is a 7-item questionnaire asking participants to describe how pain has interfered general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life. Each question is answered on a scale 0(does not interfere) to 10(completely interferes). The total range of score is 0-70. The higher the scores suggest the worse the interference.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Jiang, PhD

CONTACT

[email protected]

18980601096

Qian Li, PhD

CONTACT

[email protected]

18980601096

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.