Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery

NCT05920980 | Completed

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

Brief Summary

Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Pain scores of movement-evoked pain at postoperative 24 hours

  The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.

  up to 24 hours postoperatively

Secondary Outcomes (12)

• Pain scores of movement-evoked pain at postoperative 48 and 72 hours

  From the date of the end of surgery until the date of 72 hours postoperatively

• Pain scores of pain at rest at 24, 48 and 72 hours postoperatively

  From the date of the end of surgery until the date of 72 hours postoperatively

• The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively

  From the date of the end of surgery until the date of 72 hours postoperatively

• The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively

  From the date of the end of surgery until the date of 72 hours postoperatively

• The cumulative morphine consumption at 24, 48, and 72 hours postoperatively

  From the date of the end of surgery until the date of 72 hours postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Patients in the lidocaine groups, 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. Blood samples will be collected from some patients in the lidocaine group for the measurement of lidocaine plasma concentration.

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 2 μg/kg, granisetron 12 mg 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 groups, 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. Blood samples will be collected from some patients in the lidocaine group for the measurement of lidocaine plasma concentration.

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 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.

Also known as: placebo group

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 alanine transaminase 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 third-degree 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)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

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

• Weiming Li, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of research personnel and patients will be maintained throughout the observation period. On the day of surgery, nurses who did not participate in the perioperative management will assign the standard configuration of the trial drugs, including intraoperative medication and the configuration of the postoperative analgesic pump, to the researchers before the induction of anesthesia. Throughout the study, the patients and researchers should not be unblinded until the statistical analysis of the study data is completed. During the operation, an independent anesthesiologist will be responsible for the blood draw, and the postoperative blood samples will be collected together with the routine blood examination specimens. The investigators remained blinded throughout the observation period until the anesthesiologist or assessors observe significant adverse events of local general anesthesia toxicity.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients were randomized in a 1:1 lidocaine group, placebo control group using a computer-generated random number table. After the randomization scheme is written, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, is sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 27, 2023
• Study Start: June 5, 2023
• Primary Completion: January 13, 2025
• Study Completion: January 23, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)