An interventional study of lidocaine and Placebo in Colorectal Cancer, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by West China Hospital · Not applicable, Interventional, and Prevention
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 276 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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
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
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.
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.
The incidence of chronic pain at 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.
Time frame: 3 months postoperatively
The incidence of chronic pain at 6 months ,1 year, 3 years and 5 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.
Time frame: 6 months, 1 year and 3 years postoperatively
Overall survival after surgery
Overall survival is defined as the time between the date from surgery to the date of death.
Time frame: 6 months, 1 year, 3 years, 5 years postoperatively
Recurrence-free survival after surgery
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.
Time frame: 6 months, 1 year, 3 years, 5 years postoperatively
Disability-free surviva survival
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.
Time frame: 6 months, 1 year, 3 years, 5 years postoperatively
The prevalence of neuropathic pain
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.
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively
Brief Pain Inventory(BPI) pain interference subscale score
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.
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively
Plan to share: No
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