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

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ClinicalTrials.gov Identifier: NCT06405776
Recruitment Status : Recruiting
First Posted : May 8, 2024
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Chunling Jiang, West China Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: lidocaine Drug: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 5, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine group
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: 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.
Placebo Comparator: Placebo group
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06405776


Contacts
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Contact: Chunling Jiang, PhD 18980601096 jiang_chunling@yahoo.com
Contact: Qian Li, PhD 18980601096 jiang_chunling@yahoo.com

Locations
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China
China Recruiting
Sichuan, China
Contact: Mao Ye    13540432883    838915882@qq.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: Chunling Jiang, PhD West China Hospital
More Information
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Responsible Party: Chunling Jiang, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT06405776    
Other Study ID Numbers: 2020HX1180-2
First Posted: May 8, 2024    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Pain, Postoperative
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes
 Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action