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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2025-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06405776

Colorectal Cancer

RECRUITING NA

To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients

NCT05369650

Liver Cancer

UNKNOWN NA

Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

NCT04295330

Primary Liver Cancer

COMPLETED NA

Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

NCT02623803

Pancreatectomy

COMPLETED PHASE4

Intravenous Lidocaine for Cystectomy Procedures

NCT02924480

Invasive Bladder Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine group

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.

Group Type EXPERIMENTAL

lidocaine

Intervention Type 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.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lidocaine

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

placebo group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 alanine transaminase 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 third-degree heart block, ejection fraction \<50%);
5. Allergies to any of the trial drugs; chronic opioid use;
6. Inability to comprehend numeric rating scale.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No