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

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

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>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<br>* 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.<br>* Other names: placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores of movement-evoked pain at postoperative 48 and 72 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. | 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 | 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. | 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 | The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain. | 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 | The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain. | 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 | postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator | From the date of the end of surgery until the date of 72 hours postoperatively | 
| Time of Bowel function recovery | defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus | At 3 days after surgery | 
| The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting); | we considered it PONV if patients felt any nausea or had any vomiting | From the date of the end of surgery until the date of 72 hours postoperatively | 
| The incidence of a composite of postoperative pulmonary complications during hospitalisation | defined as positive if any component developed before discharge after surgery; | during the period from the end of surgery to discharge, an average of 7 days | 
| Length of hospital stay | Length of hospital stay | during the period from the end of surgery to discharge, an average of 7 days | 
| Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery | The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) and poor (QoR-15 < 90). | From the date of the end of surgery until the date of 72 hours postoperatively | 
| Incidence of lidocaine toxicity | such as new onset electrocardiogram (ECG) irregularities, drowsiness, light-headedness, metallic taste, peri-oral numbness, and tinnitus | From the time of anesthesia induction until the date of 72 hours postoperatively | 
| plasma lidocaine concentration | Blood samples will be collected from some patients in the lidocaine group measurement of lidocaine plasma concentration. | From the time of anesthesia induction until the date of 24hours postoperatively |