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

NCT06405776 | Recruiting

• 1 other identifier: 2020HX1180-2
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months postoperatively

Secondary Outcomes (6)

• The incidence of chronic pain at 6 months ,1 year, 3 years and 5 years postoperatively

  6 months, 1 year and 3 years postoperatively

• Overall survival after surgery

  6 months, 1 year, 3 years, 5 years postoperatively

• Recurrence-free survival after surgery

  6 months, 1 year, 3 years, 5 years postoperatively

• Disability-free surviva survival

  6 months, 1 year, 3 years, 5 years postoperatively

• The prevalence of neuropathic pain

  3 months, 6 months, 1 year, 3 years, 5 years postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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.

Lidocaine group

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.

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

China

Sichuan, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Qian Li, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: June 5, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)