Clinical trial

Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial

NCT05920980

Name

2020HX1180

Description

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

Trial arms

Trial start

2023-06-05

Estimated PCD

2024-06-01

Trial end

2024-06-01

Treatment

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.

Arms:

Lidocaine group

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.

Arms:

Placebo group

Other names:

placebo group

Size

276

Primary endpoint

Pain scores of movement-evoked pain at postoperative 24 hours

up to 24 hours postoperatively

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.\n\nDuring 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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 276, 'type': 'ESTIMATED'}}

Updated at

2023-10-11

1 organization

2 products

1 indication

Organization

Product

Indication

Product