Clinical trial NCT05920980: Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery
Official title: Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 276
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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

Detailed description: 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.

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.

Primary outcomes:
measure: Pain scores of movement-evoked pain at postoperative 24 hours
timeFrame: up to 24 hours postoperatively
Secondary outcomes:
measure: Pain scores of movement-evoked pain at postoperative 48 and 72 hours
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: Pain scores of pain at rest at 24, 48 and 72 hours postoperatively
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: The cumulative morphine consumption at 24, 48, and 72 hours postoperatively
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: Time of Bowel function recovery
timeFrame: At 3 days after surgery
measure: The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting);
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: The incidence of a composite of postoperative pulmonary complications during hospitalisation
timeFrame: during the period from the end of surgery to discharge, an average of 7 days
measure: Length of hospital stay
timeFrame: during the period from the end of surgery to discharge, an average of 7 days
measure: Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery
timeFrame: From the date of the end of surgery until the date of 72 hours postoperatively
measure: Incidence of lidocaine toxicity
timeFrame: From the time of anesthesia induction until the date of 72 hours postoperatively
measure: plasma lidocaine concentration
timeFrame: From the time of anesthesia induction until the date of 24hours postoperatively
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Weiming Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: