Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
276
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.
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.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
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.
Time frame: up to 24 hours postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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;
Time frame: during the period from the end of surgery to discharge, an average of 7 days
Length of hospital stay
Length of hospital stay
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: From the time of anesthesia induction until the date of 24hours postoperatively