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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Placebo; Drug: lidocaine

• Registration Number: NCT06405776
• Lead Sponsor: West China Hospital

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.

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 rando...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-06-05
• Status Verified: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	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.
Lidocaine group	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.

Primary Outcome Measures

Name	Time	Method
The incidence of chronic pain at 3 months postoperatively	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 ind...

Secondary Outcome Measures

Name	Time	Method
Disability-free surviva survival	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.
The prevalence of neuropathic pain	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.
Overall survival after surgery	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.
Brief Pain Inventory(BPI) pain interference subscale score	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 sug...
The incidence of chronic pain at 6 months ,1 year, 3 years and 5 years postoperatively	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 ind...
Recurrence-free survival after surgery	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.

Trial Locations

Locations (1)

China; 🇨🇳 Sichuan, China