West China Hospital
Chengdu, Sichuan, 610041, China
NCT Number: NCT05412576
patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery. Subsequently, all subjects will receive an analgesic device named Patient-Controlled Intravenous Analgesia pump, briefly, PCIA pump during the first 72 postoperative hours. PCIA pump contains lidocaine 30mg/kg, sufentanil 2 μg/kg, and granisetron 12 mg diluted to 200 mL in 0.9 % normal saline, while in the placebo group, the lidocaine will be replaced with the equal dose of 0.9% normal saline and other components unchanged. All the background infusions of PCIA will be set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injectable
Other names: IVL 0.5/1.0/1.5group
Injectable
Other names: placebo group
Time frame: The first 24 hours after surgery
The pain is evaluated using a numbering rating score(NRS).NRS scores range from 0 to 10 points, with 0 points repressing no pain,1-3points repressing mild pain, 4-6 points repressing moderate pain, 7-9 points repressing severe pain, and 10 points repressing the strongest pain.
Time frame: immediately after the operation; 24 hours after the operation
Immediately after the operation and 24 hours after the procedure, the researchers drew 3ml of blood respectively from patients to detect the blood concentration of lidocaine.
Time frame: 24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement
The pain will be evaluated using a 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 sharpest pain.
Time frame: within 72 hours after surgery
the occurrence of one or more adverse events including tingling/pins and needles, especially around the eyes and mouth, ringing in the ears, dizziness, visual disturbances, and metallic taste.
Time frame: 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 end of surgery to discharge, up to 1 week
defined as the time to first defecation or the time to first flatus
Time frame: within three days after surgery
It is defined as if patients happened any constipation, nausea, vomiting, drowsiness, dizziness, itchy skin, confusion, respiratory depression, etc.
Time frame: from the end of surgery to discharge, up to 1 week
defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis
Time frame: from the end of surgery to discharge, up to 1 month.
determined by the number of days from admittance to discharge
West China Hospital
Other
a Pilot Randomized Controlled Trial on the Safety and Efficacy of Different Doses of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery
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